Testing antiviral treatments for early COVID-19 symptoms
Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
This study is testing different antiviral treatments for people with early COVID-19 symptoms to see if they can help reduce the virus in those who are at low risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 3800 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Drugs / interventions | Sotrovimab |
| Locations | 7 sites (Minas Gerais and 6 other locations) |
| Trial ID | NCT05041907 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are previously healthy adults aged 18 to 60 with early symptomatic COVID-19 and a positive SARS-CoV-2 test.
Not a fit: Patients with chronic illnesses requiring long-term treatment or those taking certain concomitant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective antiviral treatments for early COVID-19, potentially reducing the severity of the disease.
How similar studies have performed: Other studies have shown promise with antiviral treatments for COVID-19, but this approach is innovative in its platform design and focus on early symptomatic patients.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Minas Gerais and 6 other locations
- 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)
- The Aga Khan University Hospital — Karachi, Pakistan (Terminated)
- Vajira hospital — Bangkok, Thailand (Terminated)
- Faculty of Tropical Medicine, Mahidol University — Bangkok, Thailand (Recruiting)
- Bangplee Hospital — Mueang Samut Prakan, Thailand (Terminated)
Study contacts
- Study coordinator: William Schilling, MD
- Email: william@tropmedres.ac
- Phone: +662 203 6333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.