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New treatment option for COVID-19
Official title Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
ClinicalTrials.gov ID: NCT05041907
What this study is testing
What is Nirmatrelvir/ritonavir (e.g. PAXLOVID™)?
Nirmatrelvir/ritonavir (e.g. PAXLOVID™) is an investigational medicine, being studied as a potential treatment for covid-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minas Gerais, Brazil
- Vientiane, Laos
- Kathmandu, Nepal
- Karachi, Pakistan
- Bangkok, Thailand
- Mueang Samut Prakan, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minas Gerais, Brazil; Vientiane, Laos; Kathmandu, Nepal; Karachi, Pakistan; Bangkok, Thailand; Mueang Samut Prakan, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.