An Overview of Clinical Trials for COVID-19
Gain more insight on clinical trials evaluating investigational agents for COVID-19.
There are currently no approved treatments or vaccines against coronavirus disease 2019 (COVID-19). A variety of clinical trials have been initiated in order to establish evidence around investigational drugs and to identify a vaccine candidate.
This list will be updated as clinical trials continue enrolling. The following clinical trials for COVID-19 have been posted on clinicaltrials.gov.
An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
Timeline: March 18, 2020 - April 1, 2021
Interventions: Sarilumab, Placebo.
Participants: Approximately 400
Phase 2 objective: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of severity strata.
Phase 3 objective: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 (severe and critical).
A Multi-center, Randomized, Parallel-Controlled Clinical Trial of the Application of A Hydrogen-Oxygen Generator With Nebulizer in the Improvement of Symptoms in Patients Infected With COVID-19
Timeline: February 15, 2020 - August 1, 2020
Interventions: Oxyhydrogen, Oxygen.
Participants: 100
Objective: Evaluate the efficacy and safety of Hydrogen-Oxygen Generator with Nebulizer (model AMS-H-03) as an adjuvant therapy for the patients with COVID-19 infected pneumonia in improving the clinical symptoms and reducing the incidence of severe pneumonia.
Household Transmission Investigation Study for Coronavirus Disease 2019 in French Guiana
Timeline: March 23, 2020 — March 23, 2022
Interventions: Human biological samples.
Participants: 450
Objective: To evaluate the rate of intra-household secondary transmission of the virus.
A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment
Timeline: April 8, 2020 — May 2022
Interventions: CD24Fc, Placebo.
Participants: 230
Objective: A randomized, placebo-controlled, double blind, multicenter, phase 3 trial to compare 2 COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19.
Use of cSVF For Residual Lung Damage COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral Infection
Timeline: March 25, 2020 — December 31, 2021
Interventions: Microcannula Harvest Adipose Derived tissue stromal vascular fraction, Centricyte 1000
IV Deployment Of cSVF In Sterile Normal Saline IV Solution, Liberase Enzyme (Roche), Sterile Normal Saline for Intravenous Use.
Participants: 10
Objective: Investigate the use of autologous, cellular stromal vascular fraction deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
A Pragmatic Adaptive Open Label, Randomized Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Timeline: March 31, 2020 — December 31, 2020
Interventions: Supportive Care, Supportive Care + IFX-1.
Participants: 130
Objective: Assess the clinical benefit of the treatment using the assessed clinical parameters.
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease
Timeline: March 6, 2020 — May 2020
Interventions: Remdesivir, Supportive Care.
Participants: 2400
Objective: The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Timeline: April 3, 2020 — September 30, 2021
Interventions: Tocilizumab, Placebo.
Participants: 330
Objective: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab compared with a matching placebo in combination with standard of care in hospitalized patients with severe COVID-19 pneumonia.
Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2: The HOPE Open-Label, Non Randomized Clinical Trial
Timeline: April 6, 2020 - April 30, 2021
Interventions: Chloroquine phosphate (200mg).
Participants: 60
Objective: Evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection.
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Timeline: April 1, 2020 — April 4, 2021
Interventions: Leronlimab, Placebo.
Participants: 75
Objective: Evaluate the safety and efficacy of leronlimab in patients with mild-to-moderate symptoms of respiratory illness caused by COVID-19.
A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19
Timeline: March 31, 2020 — May 2020
Interventions: Hydroxychloroquine SAR321068, Placebo
Participants: 210
Objective: Assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19
A Single-center, Open-label, Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
Timeline: March 16, 2020 - December 20, 2022
Interventions: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Participants: 108
Objective: Evaluate the safety, reactogenicity and immunogenicity of recombinant novel coronavirus vaccine (Adenovirus type 5 vector).
DAS181 for Severe COVID-19: Compassionate Use
Timeline: March 6, 2020 — April 30, 2020
Interventions: DAS181
Participants: 4
Objective: Investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.
A Randomized Controlled Open-Label Study of CM4620 Injectable Emulsion in Patients With Severe COVID-19 Pneumonia
Timeline: April 8, 2020 — September 2020
Interventions: CM4620-Injectable Emulsion
Participants: 60
Objective: Evaluate safety, efficacy, and the pharmacokinetic profile of CM4620-IE in patients with severe COVID-19 pneumonia.
A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.
Timeline: April 2, 2020 — September 2020
Interventions: Emapalumab, Anakinra
Participants: 54
Objective: Assess the efficacy and safety of Emapalumab or Anakinra, versus standard of care.
Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection
Timeline: April 8, 2020 — August 31, 2021
Interventions: Convalescent Plasma, Standard Donor Plasma
Participants: 500
Objective: Find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients.
An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Timeline: March 18, 2020 — May 31, 2020
Interventions: Danoprevir+Ritonavir
Participants: 40
Objective: Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
Timeline: April 3, 2020 — November 2020
Interventions: NO-4800, CELLECTRA 2000
Participants: 40
Objective: Evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal injection followed by electroporation using CELLECTRA 2000 device in healthy adult volunteers.
An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections
Timeline: October 24, 2017-March 31, 2021
Interventions: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
Participants: 20
Objective: Provide more data to see if nitric oxide therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years
Timeline: April 12, 2020 - January 31, 2021
Interventions: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector), Placebo
Participants: 500
Objective: Evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike protein of SARS-CoV-2.
COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)
Timeline: April 13, 2020 - August 30, 2020
Interventions: Dexamethasone
Participants: 290
Objective: Evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.
An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azytromicyn for COVID-19 Infection on Hospitalized, Noncritical Patients
Timeline: April 2020 - August 2020
Interventions: Hydroxychloroquine Oral Product, Hydroxychloroquine + azithromycin
Participants: 630
Objective: Compare standard of care, hydroxychloroquine plus azythromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19.
