COVID-19 Clinical Trial
— PLATCOVOfficial title:
Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
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 PLATCOV study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | January 2027 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal de Minas Gerais | Minas Gerais | |
Lao People's Democratic Republic | Laos-Oxford-Mahosot Wellcome Trust Research Unit | Vientiane | |
Pakistan | The Aga Khan University Hospital | Karachi | |
Thailand | Faculty of Tropical Medicine, Mahidol University | Bangkok | |
Thailand | Vajira hospital | Bangkok | |
Thailand | Bangplee Hospital | Samut Prakan |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Brazil, Lao People's Democratic Republic, Pakistan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rates of hospitalisation by treatment arm (hospitalisation for clinical reasons) | Number of hospitalisations up to Day 28 in a treatment arm with an increased rate of viral clearance compared with the negative control i.e. patients not receiving study drug | Days 0-28 | |
Other | Relationship between viral clearance, randomisation arm and other measures (covariates) and development of post- acute COVID-19 (i.e. long COVID) | Score on post-acute COVID-19 (i.e. long COVID) questionnaire at day 120 - modified COVID-19 Yorkshire Rehabilitation Scale (C19 YRSm) | Days 0-120 | |
Primary | Rate of viral clearance for interventions relative to the no study arm (This is a superiority comparison) | Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/ saliva taken daily from baseline (day 0) to day 5 for each intervention compared with the no antiviral treatment control i.e., those not receiving study drug | Days 0-5 | |
Primary | Rate of viral clearance for interventions relative to the positive control arm (This is a non-inferiority or superiority comparison). | Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/ saliva taken daily from baseline (day 0) to day 5 for interventions compared with the current best antiviral treatment option (accelerated viral clearance relative to the positive control arm) | Days 0-5 | |
Secondary | Viral kinetic levels in early COVID-19 disease | Rate of viral clearance estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/ saliva taken daily from baseline (day 0) to day 5 for each therapeutic arm compared with the no antiviral treatment control i.e., those not receiving study drug | Days 0-5 | |
Secondary | Optimal dosing regimens through pharmacometric assessment for antiviral drugs with evidence of efficacy in the literature or from the trial data (e.g., Nirmatrelvir/ritonavir, Ensitrelvir etc). | Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/ saliva taken daily from baseline (day 0) to day 5 for each therapeutic arm compared with the no antiviral treatment control i.e., those not receiving study drug | Days 0-5 | |
Secondary | Viral rebound of studied treatment arms in comparison to contemporaneous controls (e.g. no study drug arm, positive control) | After stopping treatment for at least 24 hours (or 5 days if no drug is given or a single dose monoclonal antibody is given), rebound is defined as an oropharyngeal eluate viral density estimate >1000 genomes per ml for at least 1 timepoint (average 2 swabs), after >2 consecutive days of average daily viral density estimate less than 100 genomes per ml | Days 6-14 | |
Secondary | Rates of fever clearance and symptom resolution with respect to no treatment | The following endpoints will be used: Time to resolution of fever Area Under the Curve of recorded temperature Time to resolution of symptoms |
Days 0-14 |
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