NCT05041907 Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
| NCT ID | NCT05041907 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Oxford |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,800 participants |
| Start Date | 2021-09-30 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 3,800 participants in total. It began in 2021-09-30 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 to determine in-vivo antiviral activity. In this randomized 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: Small molecule drugs; B: Monoclonal antibodies; C: Dose finding for the constituent parts of nirmatrelvir/ritonavir PLATCOV study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05041907 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05041907 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05041907 currently recruiting?
Yes, NCT05041907 is actively recruiting participants. Contact the research team at william@tropmedres.ac for enrollment information.
Where is the NCT05041907 trial being conducted?
This trial is being conducted at Minas Gerais, Brazil, Vientiane, Laos, Kathmandu, Nepal, Karachi, Pakistan and 3 additional locations.
Who is sponsoring the NCT05041907 clinical trial?
NCT05041907 is sponsored by University of Oxford. The trial plans to enroll 3,800 participants.
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