An Overview of Clinical Trials for COVID-19

April 15, 2020

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).

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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