Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
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Displaying 380 of 517Liverpool School of Tropical Medicine
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.
Assiut University
Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term. Rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." Rehabilitation might very well be a key strategy to reduce the impact of COVID-19 on the health and function of people. A team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.
Sheba Medical Center
The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo.
Mansoura University
Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies. The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.
ImmuneMed, Inc.
To explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection
Kafrelsheikh University
Efficacy of Aerosol Combination Therapy of 13 Cis Retinoic Acid and Captopril for Treating Covid-19 Patients Via Indirect Inhibition of Transmembrane Protease, Serine 2 (TMPRSS2) Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 20,000,000 people causing over 700,000 deaths. It has no currently approved treatments.Airborne SARS-CoV-2 infections in humans initiate from the virus entering nasal and airway epithelial cells through binding to angiotensin-converting enzyme 2 (ACE2). Transmembrane protease, serine 2 (TMPRSS2), a cellular protease that activates the SARS-CoV-2 spike protein, colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane. Transmembrane protease, serine 2 (TMPRSS2) is an androgen receptor signaling target gene and an androgen-regulated cell-surface serine protease expressed predominantly in prostate and lung epithelial cell. TMPRSS2 is normally expressed several folds higher in the prostate relative to any other human tissue, though the normal physiological function(s) remains unknown. A study found that dihydrotestosterone (DHT) s a potent activator of TMPRSS2.On the other hand, Feily et al noted that low-dose isotretinoin (0.5 mg/kg/day for 15-20 weeks) in PCO patients with moderate to severe nodulocystic acne resulted in significant decreases in levels of serum total testosterone, prolactin, and dihydrotestosterone A study demonstrated that 13- cis -Retinoic acid competitively and reversibly inhibits dihydrotestosterone. Therefore, we suggest that 13- cis -Retinoic acid will downregulate TMPRSS2 expression thorough temporary preventing the effect of dihydrotestosterone (DHT) on the activation of TMPRSS2 gene expression. ACE inhibitors and ARBs are commonly taken by heart patients to reduce blood pressure and to treat heart failure.Earlier studies had cautioned that this class of drugs could possibly increase the risk for the novel coronavirus, SARS-CoV-2, infection and elevate COVID-19 severity. There is conflicting observational evidence about the potential clinical impact of ACE inhibitors and ARBs on patients with COVID-19. Select preclinical investigations have raised concerns about their safety in patients with COVID-19. On the other hand, Preliminary data hypothesise that angiotensin-converting enzyme (ACE) inhibitors and renin-angiotensin- aldosterone system (RAAS) inhibitors could benefit patients with COVID-19 by decreasing acute lung damage and preventing angiotensin-II-mediated pulmonary inflammation. Here in our review, we use established and emerging evidence based on the findings of previous studies and researches to propose that ACE inhibitors may benefit patients with COVID-19 via attenuating and abolishing the effect of androgenic hormones on inducing the expression of Transmembrane protease, serine 2 (TMPRSS2), even though, at the same time, ACE inhibitors cause an increase in the human cell surface receptor protein ACE2 which the novel coronavirus uses to enter and infect cells. A study on hypertensive rats demonstrated that using ACE inhibitors(captopril) abolished and attenuated the effect of dihydrotestosterone (DHT). In this study RAS inhibition exhibited beneficial effects on androgen-induced obesity and abolished the androgen-mediated increase in blood pressure (BP) observed in this model of PCOS. (83 ± 1 vs 115 ± 3 mmHg, p
Kafrelsheikh University
Efficacy and safety of Drug combination therapy of Isotretinoin and some Anti fungal Drugs as A potential Aerosol therapy for COVID-19 : An innovative therapeutic approach The pandemic of COVID-19 which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has infected over 2,000,000 people causing over 150,000 deaths.It hasno currently approved treatments.. Airborne SARS-CoV-2 infections in humans initiate from the virus entering nasal and airway epithelial cells through binding to angiotensin-converting enzyme 2 (ACE2). TMPRSS2, a cellular protease that activates the SARS-CoV-2 spike protein, colocalizes with ACE2 and can prime SARS-CoV-2 fusion directly at the plasma membrane. In the lungs, SARS-CoV-2 infects type I and type II alveolar epithelial cells, as well as alveolar macrophages that are among the first producers of pro-inflammatory cytokines. As key components of the immediate antiviral response, type I interferons (here after referred to as IFNs) are crucial for restricting viral replication and spread, through autocrine and paracrine type I IFN receptor (IFNAR) signalling. However, minimal amounts of IFNs have been detected in the peripheral blood or lungs of patients with severe COVID-19 In a mouse model of SARS-CoV infection, local IFN responses in the lungs were delayed relative to peak viral replication, which impeded virus clearance and was associated with the development of CRS . SARS-CoV-2 ORF3b is a potent interferon inhebitor and antagonist Here, we review the molecular mechanisms by which Retinoic acid (isotretinoin) and antifungal drugs can cooperate to induce interferon in covid-19 infected patients A study reported that 13 Cis retinoic acid induced significant upregulation of toll-like receptor 3 resulting in an immune response to dsRNA intermediate which can be partially generated during CoV-2 replication . TLR3 sensitized by dsRNA and cascades of signaling pathways (Interferon-regulatory factor 1 (IRFs) and Nuclear factor-κB (NFκB) activation, respectively) are activated to produce type I interferons. The production of type I IFNs is important to enhance the release of antiviral proteins for the protection of uninfected cells. RA can be generated in multiple forms as all-trans, 9-cis,and 13-cis retinoic acid. A study reported that Retinoic acid induces directly the expression of two transcription factors, Stat1 and IRF-1 which play central roles in the IFN signal transduction. In addition, RA induces IFN-a synthesis, IFNs can serve as the first line of immune defense against viral infections. IFNs are very powerful cytokines, which play a key role in combatting pathogenic infections by controlling inflammation and immune response by directly inducing antipathogen molecular countermeasures. There are three classes of IFNs: type I, type II, and type III. Antifungal drug. Fluconazol or itraconazol can inhibit cytochrome P450 enzymes, especially cype 26 which control retinoic acid concentration into human cells enhance both isotretinoin effect and Concentrations in Target Tissues This in turn lead to hyper interferon induction and synthesis in case of COVID-19. Also a study demonstrated that isotretinoin can be given as aerosolized via inhalation rout without any damage in lung cells. Repeated high doses of 13 cis retinoic by inhalation resulted in moderate loss of body weight, but microscopic investigation of ten tissues including lung and oesophagus did not detect any significant aerosol-induced damage therefore inhaled isotretinoin might provide sufficient drug to the target cells in lung for efficacy while avoiding systemic toxicity. In conclusion,isotretinoin therapy has furthermore a proven anti-inflammatory, anti-platelet and fibrinolytic activities which may protect patients infected with covid-19 from widespread blood clots. From this point, we suggest that isotretinoin will be the immunity passport" in the context of COVID-19.
University of Baghdad
Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial
Provincial Government of Central Java, Indonesia
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.
BRAC University
In line with BRAC's overall goals to limit the COVID19 transmission, BRAC has constructed 1,000 handwashing stations coupled with other supports i.e. in-person demonstration, hygiene meetings, and soap distribution in Bangladesh. The purpose of this study is to assess the impact of public handwashing stations (HWSs) on people's hygiene behavior and health outcomes in response to the COVID-19 situation. For this, at the household level, we will collect information on self-reported handwashing practices, income, health status, and HWSs along with other relevant socio-demographic variables in detail. In addition, we will observe people's mobility, mask usage at public places, and the HWSs usage; and will associate the observed HWSs usage with their self-reported health outcomes. This study will conduct surveys on households (7,760) and public (5,820) in 20 sub-districts of Mymensingh, Khulna, and Dhaka divisions. Overall, this study is expected to directly benefit study participants and their communities by unveiling new evidence to inform BRAC's existing hygiene behavioral change programming in these communities. In addition, this information will yield future societal benefits by generating evidence on how to effectively implement and disseminate infrastructure and information that people can trust, believe, and use to form healthy hygiene habits.