COVID-19 Pipeline: Introduction

  • The coronavirus outbreak is at a tipping point, after which its development into a global pandemic may be inevitable
  • Research & development efforts by various players operating in the global COVID-19 space are now underway to investigate and develop a range of established and novel drug platforms, including prophylactic vaccines, repurposed medicines, and treatments against the virus, known as SARS-CoV-2
  • The World Health Organization is working with a number of research organizations to conduct clinical trials of existing antiviral drugs to treat patients suffering from COVID-19. For instance, the World Health Organization is collaborating with researchers in China to conduct rapid clinical trials of existing antiviral medications to treat patients infected with COVID-19.
  • On February 20, 2020, it was announced that trials have been launched in China to determine the efficacy and safety of two existing antiviral therapies: Gilead Sciences, Inc.’s nucleotide analog remdesivir, which was already under development for Ebola, and AbbVie, Inc.’s HIV combination therapy Kaletra (the combination of lopinavir and ritonavir).

Below Table Represents the COVID-19 Development Pipeline as of April 2020

NCT Number

NCT04276987

Conditions

Coronavirus

Interventions

Biological: MSCs-derived exosomes

Sponsor / Collaborators

Ruijin Hospital, Shanghai Public Health Clinical Center, Wuhan Jinyintan Hospital, Wuhan, Chin, Cellular Biomedicine Group Ltd.

Phase /  Enrollment /  Completion Date

Phase 1 / 30 /  July 31, 2020

NCT Number

NCT04317040

Conditions

Severe Coronavirus Disease (COVID-19)

Interventions

Drug: CD24Fc | Drug: Placebo

Sponsor / Collaborators

OncoImmune, Inc.

Phase /  Enrollment /  Completion Date

Phase 3 / 230 /  May, 2022

NCT Number

NCT04336410

Conditions

Coronavirus Infection

Interventions

Drug: INO-4800 | Device: CELLECTRAÂ 2000

Sponsor / Collaborators

Inovio Pharmaceuticals, Coalition for Epidemic Preparedness Innovations (CEPI)

Phase /  Enrollment /  Completion Date

Phase 1 / 40 /  November, 2020

NCT Number

NCT04333472

Conditions

COVID-19 | Coronavirus Infection

Interventions

Drug: Piclidenoson

Sponsor / Collaborators

Can-Fite BioPharma, Rabin Medical Center

Phase /  Enrollment /  Completion Date

Phase 2 / 40 /  July 6, 2020

NCT Number

NCT04334928

Conditions

Coronavirus Infection

Interventions

Drug: Emtricitabine / tenofovir disoproxil | Drug: Hydroxychloroquine | Drug: Placebo: Emtricitabine / tenofovir disoproxil Placebo | Drug: Placebo: Hydroxychloroquine

Sponsor / Collaborators

Plan Nacional sobre el Sida Servicios Para la Investigacion S.L.

Phase /  Enrollment /  Completion Date

Phase 3 / 4000 /  July 31, 2020

NCT Number

NCT04322123

Conditions

Coronavirus Infections

Interventions

Drug: Hydroxychloroquine Oral Product | Drug: Hydroxychloroquine + azithromycin

Sponsor / Collaborators

Hospital do Coracao, Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, Brazilian Research In Intensive Care Network, EMS

Phase /  Enrollment /  Completion Date

Phase 3 / 630 /  August 30, 2020

NCT Number

NCT04326426

Conditions

Coronavirus Infection

Interventions

Drug: Tradipitant | Drug: Placebo

Sponsor / Collaborators

Vanda Pharmaceuticals

Phase  /  Enrollment  /  Completion Date

Phase 3 / 300 /  August 31, 2020

NCT Number

NCT04291729

Conditions

2019-nCoV Pneumonia

Interventions

Drug: Ganovo+ritonavir+ / -Interferon nebulization

Sponsor / Collaborators

The Ninth Hospital of Nanchang, Ascletis Pharmaceuticals Co., Ltd.

Phase /  Enrollment /  Completion Date

Phase 4 / 11 /  March 19, 2020

NCT Number

NCT04299152

Conditions

Severe Acute Respiratory Syndrome (SARS) Pneumonia

Interventions

Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis

Sponsor / Collaborators

Tianhe Stem Cell Biotechnologies Inc.

Phase /  Enrollment /  Completion Date

Phase 2 / 20 /  November 10, 2020

NCT Number

NCT04315896

Conditions

COVID-19 | Severe Acute Respiratory Syndrome

Interventions

Drug: Hydroxychloroquine | Drug: Placebo oral tablet

Sponsor / Collaborators

National Institute of Respiratory Diseases, Mexico | Sanofi

Phase /  Enrollment /  Completion Date

Phase 3 / 500 /  March 22, 2021

NCT Number

NCT04321278

Conditions

Coronavirus Infections | Pneumonia, Viral

Interventions

Drug: Hydroxychloroquine + azithromycin | Drug: Hydroxychloroquine

Sponsor / Collaborators

Hospital Israelita Albert Einstein, EMS, Hospital do Coracao, Hospital Sirio-Libanes, Brazilian Research In Intensive Care Network, Cristália Produtos Químicos Farmacà uticos Ltda.

Phase /  Enrollment /  Completion Date

Phase 3 / 440 /  August 30, 2020

NCT Number

NCT04292730

Conditions

COVID-19

Interventions

Drug: Remdesivir | Drug: Standard of Care

Sponsor / Collaborators

Gilead Sciences

Phase /  Enrollment /  Completion Date

Phase 3 / 600 /  May, 2020

NCT Number

NCT04302519

Conditions

COVID-19

Interventions

Biological: Dental pulp mesenchymal stem cells

Sponsor / Collaborators

CAR-T (Shanghai) Biotechnology Co., Ltd.

Phase /  Enrollment /  Completion Date

Early Phase 1 / 24 /  July 30, 2021

NCT Number

NCT04327401

Conditions

Coronavirus Infection | Pneumonia, Viral | Acute Respiratory Distress Syndrome

Interventions

Drug: Dexamethasone

Sponsor / Collaborators

Luiz F. L. Reis, Ph.D., Hospital Israelita Albert Einstein, Hospital do Coracao, Brazilian Research In Intensive Care Network, Ache Laboratorios Farmaceuticos S.A., Hospital Sirio-Libanes

Phase /  Enrollment /  Completion Date

Phase 3 / 290 /  August 30, 2020

NCT Number

NCT03331445

Conditions

Respiratory Tract Infections | Corona Virus Infection

Interventions

Drug: Nitric Oxide 0.5 %  /  Nitrogen 99.5 % Gas for Inhalation

Sponsor / Collaborators

University of British Columbia | Mallinckrodt

Phase /  Enrollment /  Completion Date

Phase 2 / 20 /  March 31, 2021

NCT Number

NCT04311697

Conditions

Acute Respiratory Distress Syndrome | Acute Lung Injury / Acute Respiratory Distress Syndrome (ARDS) | Corona Virus Infection

Interventions

Drug: Aviptadil by intravenous infusion + maximal intensive care | Drug: Normal Saline Infusion + Maximal intensive care

Sponsor / Collaborators

NeuroRx, Inc., Relief Therapeutics Holding SA, Target Health Inc., Lavin Consulting, LLC

Phase /  Enrollment /  Completion Date

Phase 2 / 120 /  September, 2020

NCT Number

NCT04333420

Conditions

COVID-19 Pneumonia

Interventions

Drug: Best supportive Care (BSC) + IFX-1 | Drug: Best supportive care only

Sponsor / Collaborators

InflaRx GmbH

Phase /  Enrollment /  Completion Date

Phase 2 | Phase 3 / 130 /  December 31, 2020

NCT Number

NCT04315298

Conditions

COVID-19

Interventions

Drug: Sarilumab | Drug: Placebo

Sponsor / Collaborators

Regeneron Pharmaceuticals | Sanofi

Phase /  Enrollment /  Completion Date

Phase 2 | Phase 3 / 400 /  April 01, 2021

NCT Number

NCT04328285

Conditions

COVID-19

Interventions

Drug: Hydroxychloroquine | Drug: Placebo of Hydroxychloroquine | Drug: Lopinavir and ritonavir | Drug: Placebo of LPV / r Tablets

Sponsor / Collaborators

Centre Hospitalier Universitaire de Saint Etienne, Institut Pasteur

Phase /  Enrollment /  Completion Date

Phase 3 / 1200 /  November 30, 2020

NCT Number

NCT04330690

Conditions

COVID-19

Interventions

Drug: Lopinavir / ritonavir

Sponsor / Collaborators

Sunnybrook Health Sciences Centre, AbbVie

Phase /  Enrollment /  Completion Date

Phase 2 / 440 /  May 18, 2022

NCT Number

NCT04335136

Conditions

COVID-19

Interventions

Drug: RhACE2 APN01 | Drug: Physiological saline solution

Sponsor / Collaborators

Apeiron Biologics

Phase /  Enrollment /  Completion Date

Phase 2 / 200 /  November, 2020

NCT Number

NCT04313023

Conditions

COVID-19

Interventions

Drug: PUL-042 Inhalation Solution | Drug: Placebo

Sponsor / Collaborators

Pulmotect, Inc.

Phase /  Enrollment /  Completion Date

Phase 2 / 200 /  October, 2020

NCT Number

NCT04313127

Conditions

COVID-19

Interventions

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Sponsor / Collaborators

CanSino Biologics Inc., Institute of Biotechnology, Academy of Military Medical Sciences. PLA of China, Jiangsu Province Centers for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Tongji Hospital

Phase /  Enrollment /  Completion Date

Phase 1 / 108 /  December 20, 2022

NCT Number

NCT04334980

Conditions

COVID-19

Interventions

Biological: bacTRL-Spike

Sponsor / Collaborators

Symvivo Corporation

Phase /  Enrollment /  Completion Date

Phase 1 / 84 /  December 31, 2021

NCT Number

NCT04329572

Conditions

COVID-19

Interventions

Drug: Hydroxychloroquine Sulfate | Drug: Azithromycin Tablets

Sponsor / Collaborators

Azidus Brasil, PREVENT SENIOR PRIVATE OPERADORA DE SAÚDE LTDA

Phase /  Enrollment /  Completion Date

Early Phase 1 / 400 /  June 30, 2020

NCT Number

NCT04315987

Conditions

COVID-19 Pneumonia

Interventions

Biological: NestCell®

Sponsor / Collaborators

Azidus Brasil, Cellavita Pesquisa Científica Ltda, Hospital Vera Cruz

Phase /  Enrollment /  Completion Date

Phase 1 / 66 /  June, 2020

NCT Number

NCT04320615

Conditions

COVID-19 Pneumonia

Interventions

Drug: Tocilizumab (TCZ) | Drug: Placebo

Sponsor / Collaborators

Hoffmann-La Roche

Phase /  Enrollment /  Completion Date

Phase 3 / 330 /  September 30, 2021

NCT Number

NCT04334460

Conditions

Sars-CoV2

Interventions

Drug: BLD-2660

Sponsor / Collaborators

Blade Therapeutics

Phase /  Enrollment /  Completion Date

Phase 2 / 120 /  September, 2020

NCT Number

NCT04324021

Conditions

SARS-CoV-2

Interventions

Biological: Emapalumab | Biological: Anakinra

Sponsor / Collaborators

Swedish Orphan Biovitrum

Phase /  Enrollment /  Completion Date

Phase 2 | Phase 3 / 54 /  September, 2020

NCT Number

NCT04335032

Conditions

SARS-CoV-2

Interventions

Drug: Eicosapentaenoic acid gastro-resistant capsules

Sponsor / Collaborators

S.L.A. Pharma AG

Phase /  Enrollment /  Completion Date

Phase 3 / 150 /  July 31, 2020

NCT Number

NCT03808922

Conditions

Lower Respiratory Tract Infection | Parainfluenza | Immunocompromised | COVID-19

Interventions

Drug: DAS181 | Drug: Placebo | Drug: DAS181 COVID-19 | Drug: DAS181 OL

Sponsor / Collaborators

Ansun Biopharma, Inc.

Phase /  Enrollment /  Completion Date

Phase 3 / 250 /  December 28, 2021

  • Global pharma companies such as Gilead Sciences, Inc., Sanofi, and Vanda Pharmaceuticals are developing a treatment regimen for COVID-19
  • On March 24, 2020, Gilead Sciences, Inc.’s experimental drug remdesivir received orphan drug designation from the U.S. Food and Drug Administration. The drug is considered one of the potential coronavirus treatments.
  • The drug has received seven years of marketing exclusivity with the orphan drug status. According to the company’s Chairman and Chief Executive Officer Daniel O’Day, the drug will offer expanded access, compassionate use, and will treat patients with severe symptoms.
  • The company has also planned to increase the supply of the drug to more than 500,000 treatment courses by October and over 1 million treatment courses by the end of the year
  • Moreover, a Cambridge biotech company, Moderna has developed a coronavirus vaccine using a novel technology called messenger RNA (mRNA). The vaccine has been made ready in just 42 days for testing on humans. It is the first company to reach this stage of development.
  • A number of other drug developers are accelerating their programs for COVID-19 treatment. Inovio Pharmaceuticals, Inc. is developing the vaccine INO-4800 for the treatment of COVID-19. The company aims to produce 1 million doses of the INO-4800 vaccine by the end of the year to perform additional clinical trials and / or emergency use of the vaccine.
  • GSK has partnered with Clover Corp. Ltd., a China-based firm, to develop a novel protein-based COVID-19 S-Trimer vaccine. The vaccine is being developed by Clover Corp. GSK will provide Clover Corp. its pandemic adjuvant system to evaluate the drug in preclinical studies. Meanwhile, Clover Corp. is organizing its cGMP facilities in China for scale-up and mass production of the vaccine.
  • Sanofi and Regeneron Pharmaceuticals, Inc. are evaluating Sanofi’s Kevzara, (a drug used in the treatment of rheumatoid arthritis) for the treatment of the symptoms related to the coronavirus
  • On March 16, 2020, Sanofi and Regeneron Pharmaceuticals launched a phase II / III clinical study program in the U.S. The study evaluates the drug sarilumab as a treatment for severe coronavirus infection in up to 400 patients. The drug is an interleukin-6 (IL-6) receptor antagonist and was approved by the FDA in 2017 for the treatment of moderately to severely active rheumatoid arthritis in adults, who have an intolerance or inadequate response to one or more disease-modifying anti-rheumatic drugs.
  • Additionally, in February 2020, Sanofi announced that it will work with the U.S. Department of Health and Human Services (HHS) to develop coronavirus vaccine. The company’s global head of vaccine announced that the company would partner with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop the vaccine against the coronavirus using the company’s recombinant DNA platform.
  • The global pandemic situation can occur at any point like coronavirus outbreak. Hence, scientists as well as pharmaceuticals and biotech companies are attempting to develop treatments and vaccines as quickly as possible to meet the increasing unmet needs of those affected.
  • Companies such as Sanofi, Roche, Gilead Sciences, Moderna, and Regeneron Pharmaceuticals are taking efforts to develop treatments and vaccines as quickly as possible to serve the unmet needs across the globe

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COVID-19 Pipeline Assessment Overview