Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial will develop and validate a platform for quantitative assessment of antiviral effects in low-risk patients with high viral burdens and uncomplicated COVID-19. In this randomised open label, controlled, group sequential adaptive platform trial, we will assess the performance of three distinct types of intervention relative to control (no treatment):

A: potentially effective repurposed antiviral drugs;

B: Positive control: we will initially include the REGN-COV2 (monoclonal antibody cocktail); and later:

C: any future small molecule drugs that pass phase 1 testing.

PLATCOV study is funded by ACT-Accelerator Therapeutics Partnership through the Wellcome Trust. The grant reference number is 223195/Z/21/Z

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Antibodies; Antibodies, Monoclonal; Favipiravir; Ivermectin; Remdesivir

Criteria

Inclusion Criteria:

• Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study.

• Previously healthy adults, male or female, aged 18 to 50 years at time of consent with early symptomatic COVID-19

• SARS-CoV-2 positive by lateral flow antigen test

• Symptoms of COVID-19 (including fever, or history of fever) for less than 4 days (96 hours).

• Oxygen saturation ≥96% measured by pulse-oximetry at time of screening.

• Able to walk unaided and unimpeded in ADLs

• Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits

Exclusion Criteria:

The patient may not enter the study if ANY of the following apply:

• Taking any concomitant medications or drugs (see appendix 4)†

• Presence of any chronic illness/ condition requiring long term treatment, or other significant comorbidity (e.g. diabetes, obesity but see appendix 4 for the full list)

• Laboratory abnormalities discovered at screening (see appendix 4)

• For females: pregnancy, actively trying to become pregnant, or lactation

• Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics (see appendix 4)

• Currently participating in another COVID-19 therapeutic or vaccine trial

• Evidence of pneumonia (although imaging is NOT required)

• healthy women on the oral contraceptive pill are eligible to join the study