Testing antiviral treatments for early COVID-19 symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to develop a platform for assessing the antiviral effects of various treatments in low-risk patients with early symptomatic COVID-19. It will evaluate three types of interventions: small molecule drugs, monoclonal antibodies, and dose-finding for nirmatrelvir/ritonavir. Participants will be randomized into treatment groups or a control group receiving no antiviral treatment. The study focuses on patients with high viral burdens to determine the in-vivo antiviral activity of these treatments.

Why it matters

Who can join: the full rules

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 60 years at time of consent with early symptomatic COVID-19
* SARS-CoV-2 positive by lateral flow antigen test OR a positive PCR test for SARS-CoV-2 within the last 24hrs with a Ct value of less than 25 (all viral targets)
* 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

Where it's running

• Universidade Federal de Minas Gerais
  Minas Gerais, Brazil Recruiting
• Laos-Oxford-Mahosot Wellcome Trust Research Unit
  Vientiane, Laos Recruiting
• Sukraraj Tropical & Infectious Disease Hospital
  Kathmandu, Nepal Recruiting
• Faculty of Tropical Medicine, Mahidol University
  Bangkok, Thailand Recruiting
• The Aga Khan University Hospital
  Karachi, Pakistan Terminated
• Vajira hospital
  Bangkok, Thailand Terminated

Study contacts

• Study coordinator: William Schilling, MD
• Email: william@tropmedres.ac
• Phone: +662 203 6333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.