Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
NCT ID: NCT05041907
Last Updated: 2026-01-12
Study Results
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Basic Information
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RECRUITING
PHASE2
3800 participants
INTERVENTIONAL
2021-09-30
2027-01-31
Brief Summary
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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.
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Detailed Description
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A. Small molecule drugs: currently nitazoxanide, nirmatrelvir/ritonavir, hydroxychloroquine, atilotrelvir/ritonavir and metformin.
B. Monoclonal antibodies: Sotrovimab and any other monoclonal antibodies that become available. Monoclonal antibodies are vulnerable to viral escape mutations. Tracking their performance over time is important to characterise the impact and inform the therapeutics of mutant SARS-CoV-2 strains. This will also be important for other antivirals. Monoclonal antibodies are expensive and cannot be produced at large scale currently, but this may change in the near future. These drugs will be included if there is local availability and regulatory approval.
C. : Dose finding for the constituent parts of nirmatrelvir/ritonavir. Nirmatrelvir/ritonavir has shown clinical efficacy in phase III studies, however, there are disadvantages to using it (drug-drug interactions, side effects, cost). In the urgent context of the pandemic, a higher dose of ritonavir was chosen to guarantee maximum boosting effect. We do not know if the maximal boosting effect could have been achieved with less, or even without ritonavir. It will be investigated whether reducing the doses of the constituent parts can still retain the effectiveness.
Randomization to the no antiviral treatment control arm (no intervention) will be fixed at a minimum of 20% throughout the study. The randomization ratios will be uniform for all available interventions.
Recruitment into the ivermectin arm was stopped on April 18th 2022 due to meeting the pre- defined stopping criteria.
Recruitment into the remdesivir arm was stopped on June 10th 2022 due to meeting the pre- defined stopping criteria.
Recruitment into the REGN-COV2 arm was stopped on October 20th 2022 due to meeting the pre-defined stopping criteria.
Recruitment into the favipiravir arm was stopped on October 31st 2022 due to meeting the pre-defined stopping criteria.
Recruitment into the molnupiravir arm was stopped on February 22nd 2023 due to meeting the pre-defined stopping criteria.
Recruitment into the fluoxetine arm was stopped on May 8th 2023 due to meeting the pre-defined stopping criteria.
Recruitment into the evusheld arm was stopped on July 4th 2023 due to meeting the pre-defined stopping criteria.
Recruitment into the ensitrelvir arm was stopped on April 21st 2024 due to meeting the pre-defined stopping criteria.
Recruitment into the combination molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™) arm was stopped on May 31st 2024 due to meeting the pre-defined stopping criteria.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Positive control: Nirmatrelvir/ritonavir (e.g. PAXLOVID™)
Nirmatrelvir/ritonavir (e.g. PAXLOVID™)
Nirmatrelvir 300mg BD for 5/7 Ritonavir 100mg BD for 5/7
Nitazoxanide
Nitazoxanide
Nitazoxanide 1.5g BD 7/7
Molnupiravir and Nirmatrelvir/ritonavir (e.g. PAXLOVID™) [This arm is now closed to recruitment]
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
Hydroxychloroquine
Hydroxychloroquine
Hydroxychloroquine 400mg D0 BD and 400MG OD for a further 6/7
Negative control group
No treatment
No treatment (except antipyretics- paracetamol)
AZD7442 (EVUSHELD™) [This arm is now closed to recruitment]
Monoclonal antibodies
Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0
Fluoxetine [This arm is now closed to recruitment]
Fluoxetine
Fluoxetine 40mg OD for 7/7
Molnupiravir [This arm is now closed to recruitment]
Molnupiravir
Molnupiravir 800mg BD for 5/7
Sotrovimab [Pending addition]
Sotrovimab
Sotrovimab 500mg given once on D0
Ensitrelvir [This arm is now closed to recruitment]
Ensitrelvir
Ensitrelvir 375mg OD D0 and 125mg OD for a further 4/7
Positive control (REGN-COV2) [This arm is now closed to recruitment]
Monoclonal antibodies
Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0
Favipiravir [This arm is now closed to recruitment]
Favipiravir
Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7
Ivermectin [This arm is now closed to recruitment]
Ivermectin
Ivermectin 600micrograms/kg/day for 7/7.
Remdesivir [This arm is now closed to recruitment]
Remdesivir
Remdesivir 200mg D0 and 100mg for a further 4/7.
Atilotrelvir/ritonavir [Pending addition]
Atilotrelvir/ritonavir
Atilotrelvir 150mg BD for 5/7 Ritonavir 100mg BD for 5/7
Metformin (modified release) [Pending addition]
Metformin
Metformin 500mg TDS 5/7
Nirmatrelvir/ritonavir - 300/50 - dose finding [Pending addition]
Nirmatrelvir/ritonavir
Nirmatrelvir 300mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir/ritonavir - 150/50 - dose finding [Pending addition]
Nirmatrelvir/ritonavir
Nirmatrelvir 150mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir - dose finding [Pending addition]
Nirmatrelvir
Nirmatrelvir 300mg BD for 5/7
Interventions
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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
Hydroxychloroquine
Hydroxychloroquine 400mg D0 BD and 400MG OD for a further 6/7
No treatment
No treatment (except antipyretics- paracetamol)
Monoclonal antibodies
Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0
Fluoxetine
Fluoxetine 40mg OD for 7/7
Molnupiravir
Molnupiravir 800mg BD for 5/7
Sotrovimab
Sotrovimab 500mg given once on D0
Ensitrelvir
Ensitrelvir 375mg OD D0 and 125mg OD for a further 4/7
Monoclonal antibodies
Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0
Favipiravir
Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7
Ivermectin
Ivermectin 600micrograms/kg/day for 7/7.
Remdesivir
Remdesivir 200mg D0 and 100mg for a further 4/7.
Atilotrelvir/ritonavir
Atilotrelvir 150mg BD for 5/7 Ritonavir 100mg BD for 5/7
Metformin
Metformin 500mg TDS 5/7
Nirmatrelvir/ritonavir
Nirmatrelvir 300mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir/ritonavir
Nirmatrelvir 150mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir
Nirmatrelvir 300mg BD for 5/7
Nirmatrelvir/ritonavir (e.g. PAXLOVID™)
Nirmatrelvir 300mg BD for 5/7 Ritonavir 100mg BD for 5/7
Nitazoxanide
Nitazoxanide 1.5g BD 7/7
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Kaewkhao N, Tarning J, Blessborn D. LC-MS/MS Method Validation for Quantification of Nirmatrelvir in Human Plasma. Int J Anal Chem. 2025 Nov 17;2025:6625833. doi: 10.1155/ianc/6625833. eCollection 2025.
Schilling WHK, Jittamala P, Wongnak P, Watson JA, Boyd S, Luvira V, Siripoon T, Ngamprasertchai T, Batty EM, Beer E, Singh S, Asawasriworanan T, Seers T, Phommasone K, Evans TJ, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Madmanee W, Kouhathong J, Suwannasin K, Pagornrat W, Piteekan T, Hanboonkunupakarn B, Poovorawan K, Potaporn M, Srisubat A, Loharjun B, Chotivanich K, Imwong M, Pukrittayakamee S, Dondorp AM, Day NPJ, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Antiviral efficacy of oral ensitrelvir versus oral ritonavir-boosted nirmatrelvir in COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial. Lancet Infect Dis. 2025 Oct 10:S1473-3099(25)00482-7. doi: 10.1016/S1473-3099(25)00482-7. Online ahead of print.
Jittamala P, Boyd S, Schilling WHK, Watson JA, Ngamprasertchai T, Siripoon T, Luvira V, Batty EM, Wongnak P, Esper LM, Almeida PJ, Cruz C, Ascencao FR, Aguiar RS, Ghanchi NK, Callery JJ, Singh S, Kruabkontho V, Ngernseng T, Tubprasert J, Madmanee W, Suwannasin K, Promsongsil A, Hanboonkunupakarn B, Poovorawan K, Potaporn M, Srisubat A, Loharjun B, Taylor WRJ, Qamar F, Kazi AM, Beg MA, Chommanam D, Vidhamaly S, Chotivanich K, Imwong M, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV). EClinicalMedicine. 2025 Jan 18;80:103036. doi: 10.1016/j.eclinm.2024.103036. eCollection 2025 Feb.
Wongnak P, Schilling WHK, Jittamala P, Boyd S, Luvira V, Siripoon T, Ngamprasertchai T, Batty EM, Singh S, Kouhathong J, Pagornrat W, Khanthagan P, Hanboonkunupakarn B, Poovorawan K, Mayxay M, Chotivanich K, Imwong M, Pukrittayakamee S, Ashley EA, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ, Watson JA; PLATCOV Collaborative Group. Temporal changes in SARS-CoV-2 clearance kinetics and the optimal design of antiviral pharmacodynamic studies: an individual patient data meta-analysis of a randomised, controlled, adaptive platform study (PLATCOV). Lancet Infect Dis. 2024 Sep;24(9):953-963. doi: 10.1016/S1473-3099(24)00183-X. Epub 2024 Apr 24.
Luvira V, Schilling WHK, Jittamala P, Watson JA, Boyd S, Siripoon T, Ngamprasertchai T, Almeida PJ, Ekkapongpisit M, Cruz C, Callery JJ, Singh S, Tuntipaiboontana R, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Keayarsa S, Madmanee W, Aguiar RS, Santos FM, Hanboonkunupakarn P, Hanboonkunupakarn B, Poovorawan K, Imwong M, Taylor WRJ, Chotivanich V, Chotivanich K, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Clinical antiviral efficacy of favipiravir in early COVID-19 (PLATCOV): an open-label, randomised, controlled, adaptive platform trial. BMC Infect Dis. 2024 Jan 15;24(1):89. doi: 10.1186/s12879-023-08835-3.
Schilling WHK, Jittamala P, Watson JA, Boyd S, Luvira V, Siripoon T, Ngamprasertchai T, Batty EM, Cruz C, Callery JJ, Singh S, Saroj M, Kruabkontho V, Ngernseng T, Tanglakmankhong N, Tubprasert J, Abdad MY, Madmanee W, Kouhathong J, Suwannasin K, Pagornrat W, Piaraksa N, Hanboonkunupakarn P, Hanboonkunupakarn B, Poovorawan K, Potaporn M, Srisubat A, Loharjun B, Taylor WRJ, Chotivanich V, Chotivanich K, Imwong M, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Antiviral efficacy of molnupiravir versus ritonavir-boosted nirmatrelvir in patients with early symptomatic COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial. Lancet Infect Dis. 2024 Jan;24(1):36-45. doi: 10.1016/S1473-3099(23)00493-0. Epub 2023 Sep 28. Erratum In: Lancet Infect Dis. 2023 Dec;23(12):e511. doi: 10.1016/S1473-3099(23)00649-7.
Jittamala P, Schilling WHK, Watson JA, Luvira V, Siripoon T, Ngamprasertchai T, Almeida PJ, Ekkapongpisit M, Cruz C, Callery JJ, Boyd S, Anunsittichai O, Hongsuwan M, Singhaboot Y, Pagornrat W, Tuntipaiboontana R, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Keayarsa S, Madmanee W, Aguiar RS, Santos FM, Batty EM, Hanboonkunupakarn P, Hanboonkunupakarn B, Sookprome S, Poovorawan K, Imwong M, Taylor WRJ, Chotivanich V, Sangketchon C, Ruksakul W, Chotivanich K, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Clinical Antiviral Efficacy of Remdesivir in Coronavirus Disease 2019: An Open-Label, Randomized Controlled Adaptive Platform Trial (PLATCOV). J Infect Dis. 2023 Nov 11;228(10):1318-1325. doi: 10.1093/infdis/jiad275.
Schilling WHK, Jittamala P, Watson JA, Ekkapongpisit M, Siripoon T, Ngamprasertchai T, Luvira V, Pongwilai S, Cruz C, Callery JJ, Boyd S, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Piaraksa N, Suwannasin K, Hanboonkunupakarn P, Hanboonkunupakarn B, Sookprome S, Poovorawan K, Thaipadungpanit J, Blacksell S, Imwong M, Tarning J, Taylor WRJ, Chotivanich V, Sangketchon C, Ruksakul W, Chotivanich K, Teixeira MM, Pukrittayakamee S, Dondorp AM, Day NPJ, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Pharmacometrics of high-dose ivermectin in early COVID-19 from an open label, randomized, controlled adaptive platform trial (PLATCOV). Elife. 2023 Feb 21;12:e83201. doi: 10.7554/eLife.83201.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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VIR21001
Identifier Type: -
Identifier Source: org_study_id
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