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RECRUITINGPhase 2INTERVENTIONAL

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient understands the procedures and requirements and is willing and able to give willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Nirmatrelvir/ritonavir (e.g. PAXLOVID™)

Nirmatrelvir 300mg BD for 5/7 Ritonavir 100mg BD for 5/7

DRUG

Nitazoxanide

Nitazoxanide 1.5g BD 7/7

DRUG

Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™)

Molnupiravir 800mg BD for 5/7, Nirmatrelvir 300mg BD for 5/7, Ritonavir 100mg BD for 5/7

DRUG

Hydroxychloroquine

Hydroxychloroquine 400mg D0 BD and 400MG OD for a further 6/7

OTHER

No treatment

No treatment (except antipyretics- paracetamol)

DRUG

Monoclonal antibodies

Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0

DRUG

Fluoxetine

Fluoxetine 40mg OD for 7/7

DRUG

Molnupiravir

Molnupiravir 800mg BD for 5/7

DRUG

Sotrovimab

Sotrovimab 500mg given once on D0

DRUG

Ensitrelvir

Ensitrelvir 375mg OD D0 and 125mg OD for a further 4/7

DRUG

Monoclonal antibodies

Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0

DRUG

Favipiravir

Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7

DRUG

Ivermectin

Ivermectin 600micrograms/kg/day for 7/7.

DRUG

Remdesivir

Remdesivir 200mg D0 and 100mg for a further 4/7.

DRUG

Atilotrelvir/ritonavir

Atilotrelvir 150mg BD for 5/7 Ritonavir 100mg BD for 5/7

DRUG

Metformin

Metformin 500mg TDS 5/7

DRUG

Nirmatrelvir/ritonavir

Nirmatrelvir 300mg BD for 5/7 Ritonavir 50mg BD for 5/7

DRUG

Nirmatrelvir/ritonavir

Nirmatrelvir 150mg BD for 5/7 Ritonavir 50mg BD for 5/7

DRUG

Nirmatrelvir

Nirmatrelvir 300mg BD for 5/7

Locations (7)

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