Fight COVID-19 Trial

NCT04303299 | Completed Phase 3 DMC

• 1 other identifier: TH-DMS-COVID19 study
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

A 6-Week Prospective, Open label, Randomized, in Multicenter Study of, Oseltamivir 300mg per day plus Hydroxychloroquine 800 mg per day versus Combination of Lopipinavir 800mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) per day plus Oseltamivir 300mg ( or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day in mild COVID-19 and Combination of Lopipinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Lopipinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Hydroxychloroquine 400 mg per day in moderate to critically illness in COVID-19

Conditions

SARS-COV-2 Infections; COVID-19

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 eradication time

  Eradication of nasopharyngeal SARS-CoV-2

  Up to 24 weeks

Secondary Outcomes (4)

• Number of patient with Death

  Up to 24 weeks

• Number of patient with Recovery adjusted by initial severity in each arm

  Up to 24 weeks

• Number of day With ventilator dependent adjusted by initial severity in each arm

  Up to 24 weeks

• Number of patient developed Acute Respiratory Distress Syndrome After treatment

  Up to 24 weeks

Other Outcomes (2)

• Number of patient with Acute Respiratory Distress Syndrome Recovery

  Up to 24 weeks

• Time to recovery

  Up to 24 Weeks

Study Arms (8)

Oseltamivir plus Chloroquine in Mild COVID19

EXPERIMENTAL

Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 800 mg per day In mild COVID19

Drug: Oral

Darunavir and Ritonavir plus oseltamivir

EXPERIMENTAL

Darunavir 400 mg every 8 hours Ritonavir 200 mg (or 2.5 mg/kg ) per day plus plus Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 400mg per day in Mild COVID19

Drug: Oral

Lopinavir and Ritonavir plus Oseltamivir in mild COVID19

EXPERIMENTAL

Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In mild COVID19

Drug: Oral

Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19

EXPERIMENTAL

Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In moderate to critically ill COVID19

Drug: Oral

Favipiravir lopinavir /Ritonavir for mod. To severe

EXPERIMENTAL

Lopinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day in Mild COVID19 In moderate to critically ill COVID19

Drug: Oral

Darunavir /ritonavir oseltamivir chloroquine mod-severe

EXPERIMENTAL

Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19

Drug: Oral

Darunavir /ritonavir favipiravir chloroquine mod-severe

EXPERIMENTAL

Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19

Drug: Oral

Conventional Qurantine

NO INTERVENTION

Patient who unwilling to treatment and willing to quarantine in mild COVID19

Interventions

Oral DRUG

Anti virus treatment

Darunavir /ritonavir favipiravir chloroquine mod-severe; Darunavir /ritonavir oseltamivir chloroquine mod-severe; Darunavir and Ritonavir plus oseltamivir; Favipiravir lopinavir /Ritonavir for mod. To severe; Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19; Lopinavir and Ritonavir plus Oseltamivir in mild COVID19; Oseltamivir plus Chloroquine in Mild COVID19

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject.
• Able to give written inform consent and retained one copy of the consent form
• Male or female subject, aged between 16 - 100 years old.
• Subject diagnosed to be COVID19
• Female subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).
• Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.and compliance to quarantine procedure 7-14 days after treatment

You may not qualify if:

• The subject was pregnant or lactating.
• The subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.
• The subject had a known hypersensitivity to any of the test materials or related compounds.
• The subject was unable or unwilling to comply fully with the protocol.
• Treatment with investigational drug (s) within 6 months before the screening visit.
• The subject had previously entered in this study.
• Patient who planned to schedule elective surgery during the study
• The used of other antiviral agents

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Assistant Professor Subsai Kongsaengdao

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is described as 'open' unblinded, however all clinical, virological and laboratory data, as well as adverse events were reviewed by two independent physicians, and all radiological images were reviewed by two independent radiologists who were blinded to the treatment assignments. The study outcomes assessed blinded to randomized group ( PROBE design - prospective randomised open blinded evaluation)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 11, 2020
• Study Start: August 19, 2020
• Primary Completion: August 28, 2021
• Study Completion: August 28, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

TH (1)