COVID-19 future or investigational therapies
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Syed Hassan A. Kazmi BSc, MD [2]Sabawoon Mirwais, M.B.B.S, M.D.[3]
Overview
The investigational therapies for COVID-19 is an area of vast research due to its global health impact. Many world-renowned research scientists and pharmaceutical companies have joined hands to address the health impact of COVID-19 on the human race. Investigational therapies include both preventative and treatment based strategies.
Future or Investigational Therapies
Antivirals
The following pharmacological therapies are currently under investigation as potentials to treat COVID-19:
- Chloroquine/Hydroxycholoroquine
- Arbidol
- Remdesivir
- Favipiravir
Ongoing Clinical Trials
Chloroquine/Hydroxycholoroquine
- A a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis found that after high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure.[1]
- The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]).
- Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
FDA approved Phase II and III clinical trial
- Clinical Study To Evaluate The Performance And Safety Of Favipiravir in COVID-19 NCT04336904
- Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation (RuxCoFlam) NCT04338958
- Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment NCT04292730
- Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19) (CORON-ACT) NCT04335071
- A Study of Quintuple Therapy to Treat COVID-19 Infection (HAZDpaC Hydroxychloroquine, azithromycin, vitamin C, Vitamin D, zinc) [Phase II] NCT04334512
- An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
- 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
- A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment
- 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
- A Pragmatic Adaptive Open Label, Randomized Phase II/III Multicenter Study of IFX-1 in 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
- 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)
- A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19
Vaccine
Immune Targets
- The B cell and T cell epitopes derived from the spike (S) and nucleocapsid (N) proteins are currently under investigation as immune targets for development of vaccine.
- Phylogenetic similarity between SARS-CoV and COVID-19 at the level of structural proteins S, E, M, and N is providing guidance for development of a possible vaccine.
Current Clinical Trials
The following countries are currently working on the development of a vaccine for COVID-19 (SARS-CoV2)
USA
- Beth Israel Deaconess Medical Center (BIDMC), Boston and Johnson & Johnson (J&J) are currently collaborating to advance COVID-19 vaccine. A Phase I trial is expected to launch during the last quarter of 2020. AdVac and PER.C6 technologies are being used for rapid production.
- National Institute for Allergy and Infectious Diseases (NIAID) has announced that a phase 1 trial has begun for COVID-19 immunization in Washington state.
- The trial includes 45 young, healthy volunteers with different doses of immunization shots co-developed by NIH and Moderna Inc.
Israel
- Researchers at Israel’s Institute for Biological Research are expected to announce in the coming days that they have completed development of a vaccine for COVID-19
China
- China was the first country to release the genetic sequence of the virus on open scientific databases so that research institutes and commercial companies could try to develop treatments and vaccines without needing to obtain samples.
- China has announced the first animal tests.
Australia
- Following successful in vitro experiments, animal testing has begun in University of Queensland in Australia
Prior Work
The following table depicts major vaccine products that have been developed against SARS-CoV and MERS-CoV:[2][3]
| Vaccine Base | Antigen | Clinical Testing | Pros | Cons |
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| DNA |
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Phase I, II
(NCT03721718) |
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| Viral Vector |
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Phase I
(NCT03399578, NCT03615911) |
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| Conjugated subunit |
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| Virion |
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| Inactivated |
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| Live attenuated |
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Randomized Clinical Trials
| Country | Name | Objective | Date | Strategy | Outcome |
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| Hydroxychloroquine
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To evaluate the efficacy of hydroxychloroquine (HCQ) in the treatment of patients with COVID-19
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February 4 to February 28, 2020
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| UK | Hydroxychloroquine
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References
- ↑ Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH (June 2020). "A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19". N. Engl. J. Med. doi:10.1056/NEJMoa2016638. PMID 32492293 Check
|pmid=value (help). - ↑ Song Z, Xu Y, Bao L, Zhang L, Yu P, Qu Y, Zhu H, Zhao W, Han Y, Qin C (January 2019). "From SARS to MERS, Thrusting Coronaviruses into the Spotlight". Viruses. 11 (1). doi:10.3390/v11010059. PMC 6357155. PMID 30646565.
- ↑ Schindewolf C, Menachery VD (January 2019). "Middle East Respiratory Syndrome Vaccine Candidates: Cautious Optimism". Viruses. 11 (1). doi:10.3390/v11010074. PMC 6356267. PMID 30658390.