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.
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
Apeptico GmbH
APEPTICO's solnatide IMP has been approved for Compassionate Use by the Austrian Federal Office for Safety in Health Care (BASG) for the treatment of patients infected by the novel coronavirus SARS-CoV-2 and subsequently developing severe pulmonary dysfunction (severe COVID-19). APEPTICO, a privately-held biotechnology company from Vienna, Austria, is developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B).
Capricor Therapeutics
Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy - CAP-1002 mitigates the release of anti-inflammatory cytokines as well as macrophage activation in a number of models of inflammation including sepsis and autoimmune diseases.
CAP-1002 in Severe COVID-19 Disease - Compassionate Use Program
New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 - Over the course of one month, six critically ill COVID-19 patients, all suffering from acute respiratory distress syndrome (ARDS) and five of whom were on mechanical ventilatory support, were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged.
Disease/Category-Specific EA Policies/Criteria
CAP-1002 in Severe COVID-19 Disease - Compassionate Use Program
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.
Implicit Bioscience Ltd
Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19) - This protocol proposes to use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing human CD14, to block CD14-mediated cellular activation in patients early in the development of ARDS. The binding of IC14 to human CD14 prevents CD14 from participating in the recognition of PAMPs and DAMPs due to SARS-CoV-2 infection. The putative mechanism of action of IC14 in ARDS is blockade of PAMP and DAMP interactions with CD14, thus attenuating the inflammatory cascade that leads to increased endothelial and epithelial permeability and injury resulting in alveolar injury and fluid accumulation characteristic of ARDS.
Available Therapies via Single-Patient EA
Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)
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.
Innovation Pharmaceuticals, Inc.
Innovation has received inquiries asking about Brilacidin’s potential to treat the coronavirus (COVID-19) given the urgent worldwide need to find effective treatments for this deadly epidemic.
For more information, contact: covid19@ipharminc.com
The linked PDF (click here), updated on March 1, is an informational overview summarizing the scientific rationale for Brilacidin as a potential coronavirus (COVID-19) treatment. Brilacidin, and other defensin-mimetics similar in structure, have been tested against various clinical isolates of both gram-positive and gram-negative pathogens, with strong activity exhibited across multiple isolates. Enveloped viruses, like the coronavirus, have also been tested, with activity noted. University of Pennsylvania scientists who conducted early Brilacidin research are optimistic about the multi-tiered advantages of Brilacidin to elicit a response, particularly when accompanied by drug optimization, formulation and delivery work, which is supported in the academic literature.
Izana Bioscience
This study is in cooperation with the Humanitas research group, under the leadership of Professor Carlo Selmi, head of the Rheumatology and Clinical Immunology Unit at Humanitas Research Hospital and Associate Professor of Internal Medicine at Humanitas University. The study will take place in Bergamo and Milan, Italy.
Namilumab is the Company’s wholly-owned, phase III-ready, fully human monoclonal antibody therapy targeting granulocyte-macrophage colony stimulating factor (GM-CSF), currently in late-stage clinical development for the treatment of rheumatoid arthritis and ankylosing spondylitis.
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.
Pluristem Therapeutics, Inc.
Pluristem Expands its Compassionate Use Program: Treated First COVID-19 Patient in U.S. Under FDA Single Patient Expanded Access Program - The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s Phase III critical limb ischemia (CLI) study. Prior to treatment with PLX, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation in an intensive care unit (ICU) for three weeks.
- All treated patients were in Intensive Care Units (ICU) on ventilators and suffered from Acute Respiratory Distress Syndrome (ARDS)
- 100% survival rate for all seven patients
- 6 patients completed 1 week follow up; the seventh patient was treated on April 5 2020
- 4 of the 6 (66%) patients that completed 1 week follow up demonstrated improvement in respiratory parameters
- 3 of the 6 (50%) patients that completed 1 week follow up are in advanced stages of weaning from ventilators
- Pluristem plans to apply for initiation of multinational clinical trial for treatment of complications associated with COVID-19
For more information: https://www.pluristem.com/wp-content/uploads/2020/04/PSTI-COVID-19-First-Patient-in-US-FINAL-FOR-RE… and https://www.pluristem.com/wp-content/uploads/2020/04/PSTI-PR-Follow-up-on-Covid-19-treatments-FINAL-FOR-RELEASE.pdf
RedHill Biopharma Ltd
Opaganib - COVID-19 - RedHill is working to develop opaganib (Yeliva, ACB294640) for COVID-19. Opaganib has a unique mechanism of action, with both anti-inflammatory and anti-viral activity, targeting a critical host factor, which minimizes the potential development of resistance due to viral mutations. RedHill is advancing a development program evaluating opaganib as a therapy for patients with severe COVID-19 infection, which includes two ongoing clinical studies:
- A global randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study (NCT04467840)
- A U.S. randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618)
RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico - The global Phase 2/3 study with opaganib is set to enroll up to 270 patients with severe COVID-19 across 40 clinical site. The global Phase 2/3 study has been approved in Mexico, the UK and Russia and is also under review in Italy, Brazil and additional countries. Enrollment in a parallel U.S. Phase 2 study in patients with severe COVID-19 is approximately 50% complete and is expected to be completed this month. Potential submission of global emergency use applications planned as early as Q4/2020.
RedHill Biopharma Announces Approval of Compassionate Use of Opaganib for COVID-19 in Italy
RedHill Announces First COVID-19 Patient Treated with Opaganib in Israel Under Compassionate Use
Available Therapies via Single-Patient EA
COVID-19 - Yeliva (opaganib)
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
VERO Biotech LLC
VERO Biotech is increasing its commitment to support the treatment of patients afflicted with complications of COVID-19 with GENOSYL® Delivery System (DS), the first and only FDA-approved tankless system for the delivery of inhaled nitric oxide. As a result of the first patient treated at home with GENOSYL® (nitric oxide) gas for inhalation, and the ongoing COVID-19 pandemic, VERO’s three-point response includes:
- Emergency access of GENOSYL to patients with COVID-19 complications for outpatient treatment
- Access to local Atlanta-based hospitals via Emergency Treatment Protocol (ETP)
- Significant increase in local Atlanta hiring to meet production demand for GENOSYL
Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate.
For more information: https://www.vero-biotech.com/vero-biotech-commits-to-atlanta-healthcare-providers-patients-and-hiring-expansions-during-covid-19-pandemic/