COVID-19 Company Directory
The commercial organizations listed in this directory have announced they are conducting clinical research on treatment for COVID-19, often in association with academic partners. When available, contact information is included as are brief descriptions of the interventions being explored. Science is moving rapidly to address this global crisis, so new listings will be added as more companies and therapies move into clinical stages. Please feel free to check this directory often.
You may opt to further streamline your search by using the Stage and Type options. Simply click one or more of those boxes to refine your search. To find Clinical Trials and Expanded Access programs, please search here.
Akari Therapeutics
Akari Therapeutics Announces International Clinical Development Program of Nomacopan for the Potential Treatment of COVID-19 Pneumonia - Akari Therapeutics, Plc (Nasdaq: AKTX), a Phase III biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces its intention to develop nomacopan as a potential treatment for COVID-19 pneumonia through integrated clinical trial programs in U.S., U.K. and Brazil.
- Nomacopan has been shown in clinical trials to inhibit both complement C5 activation and leukotriene B4 (LTB4), and has significant potential to simultaneously inhibit both microthrombi as well as block multiple cytokines (the cytokine storm) which together drive COVID-19 pneumonia and associated organ damage.
- Ongoing clinical readouts expected throughout remainder of 2020
Akari Therapeutics Reports Second Quarter 2020 Financial Results and Highlights Recent Clinical Progress - Akari Therapeutics, a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, announced financial results for the second quarter ended June 30, 2020, as well as recent clinical progress.
- Pivotal Phase III study in patients with bullous pemphigoid (BP) expected to start H1 2021 following recent successful end-of-Phase II meeting with FDA
- Enrollment in the pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) pivotal program expected to commence in Q4 2020
Clinical Study: Coronet 1 Emergency Use study at UC Health
Alexion
Alexion Announces Plans to Initiate Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19 - Alexion announced plans to initiate a global Phase 3 study to investigate ULTOMIRIS® (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS). The study is expected to enroll approximately 270 patients across countries with high numbers of diagnosed cases, and will evaluate the impact of ULTOMIRIS, a biologic medicine, on survival, duration of mechanical ventilation, and hospital stay compared to best supportive care.
Alexion Statement on SOLIRIS® (eculizumab) and COVID-19 - Alexion has provided SOLIRIS as an experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia. Requests are assessed on a case-by-case basis, with priority given to those with clinical trial experience and the oversight of a physician who has extensive experience using SOLIRIS.
Emergency Treatment for COVID-19 https://alexion.com/our-commitment/global-access-to-medicines
For more information, contact us at covid.requests@alexion.com.
Disease/Category-Specific EA Policies/Criteria
Emergency Treatment for COVID-19 https://alexion.com/our-commitment/global-access-to-medicines
Alexion has provided SOLIRIS as an experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia. Requests are assessed on a case-by-case basis, with priority given to those with clinical trial experience and the oversight of a physician who has extensive experience using SOLIRIS.
For more information, contact us at covid.requests@alexion.com.
Eculizumab (Soliris) in Covid-19 Infected Patients (Expanded Access Study)
ULTOMIRIS® (ravulizumab-cwvz) - the first and only long-acting C5 complement inhibitor
Algernon Pharmaceuticals
Algernon Announces 50% Enrollment in Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 - Algernon has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The Company is now projecting that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020. The multinational Phase 2b/3 human trial for COVID-19 is entitled, "A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease." The trial has begun as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.
Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial - NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils. The trial will begin as a Phase 2b study and after an interim analysis is performed on the first 100 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial. With positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3.
Read more here: https://algernonpharmaceuticals.com/covid-19-global-treatment-initiatives/
AstraZeneca Pharmaceuticals LP
Phone Number & Email
COVID-19 vaccine AZD1222 clinical trials resumed in the UK - Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.
University of Oxford potential COVID-19 vaccine Phase III clinical trial initiated in the US - Development of the potential COVID-19 vaccine has expanded into a Phase III clinical trial in the US to assess the safety, efficacy and immunogenicity of the potential vaccine for the prevention of COVID-19. The trial is funded by US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.
Available at: https://clinicaltrials.gov/ct2/show/NCT04516746?term=NCT04516746&draw=2&rank=1
D8110C00001 is a Phase III randomised, double-blind, placebo-controlled multicentre study assessing the safety, efficacy, and immunogenicity of AZD1222 compared to placebo for the prevention of COVID-19, in up to 30,000 participants across approximately 100 trial centres in and outside the US. Trial participants aged 18 years or over who are healthy or have medically stable chronic diseases, and are at increased risk for being exposed to the SARS-CoV-2 virus and COVID-19 will be randomised in a 2:1 ratio to receive two intramuscular doses of either 5 x1010 viral particles of AZD1222 or saline placebo four weeks apart, on day one and 29. Randomisation will be stratified by age (≥ 18 to < 65 years, and ≥ 65 years), with at least 25% of participants to be enrolled in the older age range. Individuals interested in participating in the Phase III D8110C00001 vaccine trial can visit https://www.c19vaccinestudy.com or www.CoVPN.org websites for more information.
Researching antibodies to target COVID-19 - More than 50 virology, protein engineering, clinical and bioprocess experts across BioPharmaceuticals R&D and Operations are working on this effort, using proprietary antibody discovery technology that was previously developed under an agreement with the US Defense Advanced Research Projects Agency (DARPA) as part of the Pandemic Preparedness Platform program. As part of the DARPA program, the technology enabled AstraZeneca scientists to rapidly discover potential therapeutic antibodies for influenza-A in less than 60 days. The Chinese Academy of Sciences (China) and Vanderbilt University Medical Center (US) are providing AstraZeneca with genetic sequences for antibodies they have discovered against SARS2-CoV-2 for further in silico and in vitro assessment.
Athersys, Inc.
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
We are running a Pivotal Phase 2/3 clinical trial evaluating MultiStem cell therapy in COVID-19 induced ARDS patients. This trial is a multicenter study with an open-label, single active treatment arm for cohort 1 followed by a double-blind, randomized, placebo-controlled Phase 2/3 portion. The primary objectives of the MACOVIA study are to evaluate the safety and efficacy of MultiStem therapy as a treatment for subjects with moderate to severe ARDS due to COVID-19.
For more info: https://www.athersys.com/clinical-trials/ards/default.aspx
Eli Lilly
Lilly Announces Proof of Concept Data for Neutralizing Antibody LY-CoV555 in the COVID-19 Outpatient Setting - Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).
see: https://clinicaltrials.gov/ct2/results?cond=&term=nct04497987&cntry=&state=&city=&dist=
Lilly's Neutralizing Antibodies and COVID-19 Fact Sheet
Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial - Lilly announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.
Eli Lilly and Company announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study Olumiant (baricitinib) as an arm in NIAID's Adaptive COVID-19 Treatment Trial. Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®, is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Given the inflammatory cascade seen in COVID-19, baricitinib's anti-inflammatory activity has been hypothesized to have a potential beneficial effect in COVID-19 and warrants further study in patients with this infection. https://investor.lilly.com/news-releases/news-release-details/lilly-begins-clinical-testing-therapies-covid-19
AbCellera and Lilly to Co-develop Antibody Therapies for the Treatment of COVID-19 - AbCellera and Lilly will select from 500+ unique antibodies isolated from one of the first U.S. patients who recovered from COVID-19 to create antibody therapeutics for treatment and prevention of COVID-19
Fujifilm Toyama Chemical Co. Ltd.
Fujifilm announces the start of a phase III clinical trial of influenza antiviral drug “Avigan Tablet” on COVID-19 and commits to increasing production
For more information: https://www.fujifilm.com/jp/en/news/hq/3211?_ga=2.116910662.1504568395.1585764405-146260470.1585764405
Information of Avigan Tablet in relation to COVID-19
Avigan Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug. The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. Thus, while the Japanese government has a certain stockpile of the drug, Avigan Tablet has never been distributed in the market and is not available at hospitals and pharmacies in Japan or overseas.
Favipiravir, the active pharmaceutical ingredient of Avigan Tablet, has a mechanism of action that prevents the propagation of viruses. The drug may potentially have an antiviral effect on the novel coronavirus as it is classified into the same type (single-stranded RNA virus) as influenza virus. However, at this stage, clinical application of Avigan Tablet to treat Coronavirus disease (Covid-19) is under study and preparation in order to obtain clear evidence of the drug's efficacy and safety.
Avigan Tablet has not been approved for marketing in any countries other than Japan. If any other national government or regulatory authority decides the use of Avigan Tablet, Fujifilm group intends to cooperate sincerely with the supply of Avigan Tablet to such countries in consultation and coordination with the Japanese government.
Marketed as Favilavir by Zhejiang Hisun Pharmaceuticals (China)
Fulcrum Therapeutics
Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients - The LOSVID trial is a Phase 3, international, multicenter trial designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation.
For more information, email clinicaltrials@fulcrumtx.com.
Genentech
On March 23, 2020, we announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial (COVACTA) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. Learn more about the COVACTA clinical trial here.
Additionally, to further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS).
Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k
Single-Patient EA Policies/Criteria
https://www.gene.com/patients/investigational-medicines/criteria
Gilead Sciences, Inc.
COVID-19 Resource Page
Expanded Access Remdesivir (RDV; GS-5734™) - for DOD/military personnel only
Emergency Access to Remdesivir Outside of Clinical Trials
An Open Letter from our Chairman and CEO (March 28, 2020)
An Update on COVID-19 from our Chairman & CEO (April 4, 2020)
"Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations."
Disease/Category-Specific EA Policies/Criteria
Emergency Access to Remdesivir Outside of Clinical Trials
Expanded Access Remdesivir (RDV; GS-5734™) - for DOD/military personnel only
Humanigen, Inc.
Phase III clinical trial to evaluate lenzilumab for the prevention and treatment of cytokine storm arising from COVID-19.
- Lenzilumab neutralizes granulocyte macrophage colony stimulating factor (GM-CSF) a key cytokine in the initiation of cytokine storm
- GM-CSF is up-stream of interleukin-6 (IL-6) in the development of cytokine storm
- GM-CSF is up-regulated in COVID-19 patients and may cause a harmful immune response, which contributes to cytokine storm in patients at risk of developing acute respiratory distress syndrome (ARDS)
FDA Approves Emergency IND Use of Humanigen’s Lenzilumab for Compassionate Use in COVID-19 Patients
Lenzilumab for Compassionate Use - Humanigen is now accepting enquiries regarding lenzilumab for compassionate use.
Incyte, Inc.
Incyte Announces Plans To Initiate A Phase 3 Clinical Trial Of Ruxolitinib (Jakafi®) As A Treatment For Patients With COVID-19 Associated Cytokine Storm - Incyte also intends to launch an Expanded Access Program in the United States to allow eligible patients with COVID-19 associated cytokine storm to receive Jakafi (ruxolitinib). (Jakavi/Jakafi is marketed by Novartis outside the United States. In the United States, the product is marketed by Incyte, Inc.)
As the Phase 3 study and EAP protocols are awaiting potential approval by the FDA, questions or inquiries regarding the availability of ruxolitinib for compassionate use or independent research should be made to:
U.S. Medical Information
1-855-4MED-INFO (1-855-463-3463)
medinfo@incyte.com.
Single-Patient EA Policies/Criteria
Questions or inquiries regarding the availability of ruxolitinib for compassionate use or independent research should be made to:
U.S. Medical Information
1-855-4MED-INFO (1-855-463-3463)
medinfo@incyte.com.
Mesoblast Ltd
US NIH Trials Network to Conduct COVID-19 Phase 2/3 Trial - Mesoblast Limited has announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials.
Moderna, Inc.
Moderna Confirms Discussions with the Ministry of Health, Labour and Welfare to Supply Japan with 40 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna confirmed that the Company is engaged in discussions with the Ministry of Health, Labour and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the public as soon as possible. Under the terms of this arrangement, the vaccine would be supplied by Moderna, Inc. and distributed in Japan by Takeda Pharmaceutical Co., Ltd. (NYSE: TAK) beginning in the first half of 2021, if the vaccine receives regulatory approval. Kato Katsunobu, Minister of MHLW, announced the discussions in a meeting with media today in Japan.
Moderna to Present New Interim Clinical Data About mRNA Vaccine Against COVID-19 (mRNA-1273) at Advisory Committee on Immunization Practices (ACIP) Meeting - Moderna announced its presentation at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) August Meeting. The live presentation can be viewed online here.This presentation includes new interim safety and immunogenicity data from the cohorts of older adults in the NIH-led Phase 1 study of mRNA-1273, Moderna’s vaccine candidate against COVID-19. The ACIP presentation slides will be available under “Events and Presentations” in the Investors section of the Moderna website.
Moderna Confirms Advanced Discussions with European Commission to Supply Europe with 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna has concluded advanced exploratory talks with the European Commission to supply 80 million doses of mRNA-1273 as part of the European Commission’s goal to secure early access to safe and effective COVID-19 vaccines for Europe.The potential purchase agreement with the European Commission of 80 million doses provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The discussions are intended to ensure that Member States have access to Moderna’s vaccine. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September.
Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - The U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, this announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion.
Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus - Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
see also: https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19 - This page summarizes key milestones to advance mRNA-1273, Moderna's vaccine candidate against the novel coronavirus.
NIH/National Institute on Allergy and Infectious Diseases/Vaccine Research Center
Read more about developing therapeutics and vaccines for coronaviruses
NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells. NIAID conducted a phase 1 clinical trial of SAB-301, an experimental MERS treatment developed from cattle that make human antibodies. This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated. Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.
NIH clinical trial of investigational vaccine for COVID-19 begins
Disease/Category-Specific EA Policies/Criteria
Developing Therapeutics and Vaccines for Coronaviruses
https://www.niaid.nih.gov/diseases-conditions/coronaviruses-therapeutics-vaccines
NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells. NIAID conducted a phase 1 clinical trial of SAB-301, an experimental MERS treatment developed from cattle that make human antibodies. This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated. Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.
NIH clinical trial of investigational vaccine for COVID-19 begins
Novartis Pharmaceuticals
COVID-19 Information Center https://www.novartis.com/coronavirus
Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program - Novartis to establish compassionate use program for COVID-19 patient access and undertake steps to ensure uninterrupted supply of Jakavi for currently licensed indications. (Jakavi/Jakafi is marketed by Novartis outside the United States. In the United States, the product is marketed by Incyte, Inc.)
The multiple sclerosis drug Gilenya and fever drug Ilaris are also being studied for their effect on complications related to COVID-19.
Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial. For more information:
https://newsroom.uw.edu/news/does-antimalarial-drug-prevent-covid-19-study-seeks-answers
https://depts.washington.edu/covid19pep/
Novartis donation: Consignment of 30 million hydroxychloroquine tablets ships to US Department of Health and Human Services
Available Therapies via Single-Patient EA
Novartis considers granting managed access to investigational or pre-approval products via single patient access provided the Managed Access criteria are fulfilled.
Regeneron
RECOVERY COVID-19 phase 3 trial to evaluate REGENERON'S REGN-COV2 investigational antibody cocktail in the UK - Regeneron and the University of Oxford announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.
REGENERON Announces Start of REGN-COV2 Phase 3 Covid-19 Prevention Trial in Collaboration With National Institute Of Allergy And Infectious Diseases (NIAID) - A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.
Developing REGN-COV2 (see: https://www.regeneron.com/covid19) - REGN-COV2 is a novel anti-viral antibody cocktail that is being studied for its potential both to treat people with COVID-19 and to prevent SARS-CoV-2 infection. REGN-COV2 is currently being studied in four late-stage clinical trials: two Phase 2/3 trials for the treatment of hospitalized and non-hospitalized (“ambulatory”) COVID-19 patients, the open-label, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient (such as the patient’s housemate). The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The safety of REGN-COV2 is also being evaluated in a Phase 1 healthy volunteer study.
If you are interested in participating in one of Regeneron's COVID-19 clinical trials, please complete a brief online screener at ClinLife.com/COVID to see if you qualify.
Based on recent clinical data from studies in China with another IL-6 inhibitor, we believe there is a potential role for Kevzara® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with our collaborators at Sanofi, we are conducting controlled clinical studies to evaluate Kevzara in this setting. The use of Kevzara to treat people with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
For more info, go to: Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
See also Sanofi in company directory.
Roche
Frequently requested information about Roche medicines and COVID-19: https://medinfo.roche.com/
Includes fact sheets on:
Actemra/RoActemra (tocilizumab) - Download
Ocrevus (ocrelizumab) - Download
Tamiflu (oseltamivir) - Download
Roche statement on coronavirus (Update 19.03.2020)
Other companies mentioned/involved: Chugai Pharmaceuticals; Zhejiang Hisun Pharmaceuticals
Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k
Sanofi
- Phase 2/3 trial initiated in Italy, Spain, Germany, France, Canada and Russia and is enrolling patients immediately
- Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection
- Sanofi is leading trials outside the U.S., while Regeneron is leading U.S. trials
For more info, go to: Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
See also Regeneron in the company directory
Sanofi and Translate Bio collaborate to develop novel mRNA vaccine candidate against COVID-19
Vanda Pharmaceuticals, Inc.
Vanda Pharmaceuticals, Northwell Health Conduct ODYSSEY Trial In Patients With Severe COVID-19 Pneumonia - Enrollment of the first patient in Vanda's clinical trial, ODYSSEY VLY-686-3501 (NCT04326426), at Lenox Hill Hospital in New York City. ODYSSEY is a Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection. This novel coronavirus is associated with a lower respiratory tract inflammation that often progresses to Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation.
See also: