With the pandemic of COVID-19 affecting the way of life across the globe, companies continue to accelerate the clinical development of a vaccine or a therapeutic. The number of Covid-19 clinical trials has been steadily growing because of the increases in incidence and mortality rates.
A few phase II and IV trials investigating therapeutics for COVID-19 have been completed (see Table 1 below). With regards to these trials:
- all were sponsored by Chinese hospitals
- all trials were conducted in China and most had a low patient n
- all the primary interventions administered were therapeutics, not vaccines.
Therefore, the results reported so far, even though some trials are promising, do not bring to light any remarkable drug candidates. The data reported are from a handful of single-country trials with a limited number of subjects. It is hopeful that the ongoing and planned upcoming trials listed below may bring more insight.
Table 1. Created from information available on ClinicalTrials.gov.
Vaccine Candidates
A Phase I first-in-human vaccine trial was initiated in March by the National Institute of Allergy and Infectious Diseases (NIAID) with Moderna’s mRNA-1273. This trial is testing mRNA-1273 in 45 healthy adult male and non-pregnant female subjects. The estimated trial end date is June, 2021.
Other vaccine candidates include:
- Regeneron’s REGM3048-3051: in preclinical testing, phase I begins early summer
- Inovio Pharmaceuticals’ INO-4800: in preclinical testing, phase I begins April 2020
- Pfizer/Biontech’s unnamed vaccine: phase I begins April 2020
- Sanofi’s unnamed vaccine: potential phase I begins April 2021
- Johnson & Johnson/Janssen Pharmaceutical’s unnamed vaccine: phase I starts by September and first use in early 2021.
- Unnamed Vaccine by Novavax/Emergent Biosolutions’ unnamed vaccine: phase I expected to begin late spring 2020
Novel Pharmacological Candidates
- EIDD-2801 by Emory Drug Innovation Ventures is an oral treatment taken at the onset of SARS, MERS, Ebola, and Influenza. It is in preclinical testing for the treatment of COVID-19.
- The anti-viral prophylactic and treatment, Piclidenoson, by Can-Fite has completed phase I and II clinical trials for rheumatoid arthritis (RA).
Candidates for Off-Label Use
- Clinical trials have started on Sanofi, Sandoz’s malaria, lupus, and RA treatment hydroxychloroquine. FDA has issued guidance that hydroxychloroquine should be prescribed to hospitalized adolescent and adult Covid-19 patients when enrollment in a clinical trial is not practicable.
- Eli Lilly’s RA treatment Olumint is in preclinical testing for the treatment of COVID-19.
- Favirpiravir, for the treatment of influenza, by Fujifilm Toyama Chemical is being tested for the normilization of fever in patients within the first 4 days of COVID-19 diagnosis. To date, it has been effective in those without severe symptoms.
- Roche’s FDA approved RA treatment Actemra is being studied for the treatment of Covid-19-related severe lung inflammation.
- Regeneron and Sanofi’s RA treatment Kevzara (sarilumab) is being studied for the treatment of Covid-19-related severe lung inflammation.
- Clinical trials are beginning on Gilead Sciences’ Ebola medication remdesivir.
- A clinical trial in China with 20 subjects of the HIV medication Kaletra/Aluvia was inconclusive. A clinical trial of 2400 subjects is upcoming.
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