A 6 Week Prospective, Open Label, Randomized, in Multicenter Study of, Oseltamivir Plus Hydroxychloroquine Versus Lopipinavir/ Ritonavir Plus Oseltamivir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine in Mild COVID-19 AND Lopipinavir/ Ritonavir Plus Oseltamivir Versus Favipiravir Plus Lopipinavir / Ritonavir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine Versus Favipiravir Plus Darunavir and Ritonavir Plus Hydroxychloroquine in Moderate to Critically Ill COVID-19
Latest Information Update: 04 Nov 2021
At a glance
- Drugs Chloroquine (Primary) ; Darunavir/ritonavir (Primary) ; Favipiravir (Primary) ; Hydroxychloroquine (Primary) ; Lopinavir (Primary) ; Lopinavir/ritonavir (Primary) ; Oseltamivir (Primary) ; Ritonavir (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- Acronyms FIGHT-COVID-19
- 28 Aug 2021 Status changed from recruiting to completed.
- 19 Aug 2020 Planned End Date changed from 30 Mar 2021 to 31 Dec 2021.
- 19 Aug 2020 Planned primary completion date changed from 31 Dec 2020 to 31 Dec 2021.
Most Recent Events
Trial Overview
Purpose
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
Primary Endpoints
SARS-CoV-2 eradication time
description: Eradication of nasopharyngeal SARS-CoV-2
time_frame: Up to 24 weeks
Other Endpoints
Number of patient with Death
description: Any death after treatment adjusted by initial severity in each arm time_frame: Up to 24 weeks
Number of patient with Recovery adjusted by initial severity in each arm
description: Normal pulmonary function, normal O2 saturation after treatment Adjusted by initial severity in each arm time_frame: Up to 24 weeks
Number of day With ventilator dependent adjusted by initial severity in each arm
description: Number of day with ventilator assistant time_frame: Up to 24 weeks
Number of patient developed Acute Respiratory Distress Syndrome After treatment
description: Number of patient developed new ARDS time_frame: Up to 24 weeks
Number of patient with Acute Respiratory Distress Syndrome Recovery
description: Acute Respiratory Distress Syndrome Recovery rate time_frame: Up to 24 weeks
Time to recovery
description: The time to recovery was defined as the time between the first day of antiviral treatment or hospitalization to the day when there was no further requirement for antiviral medication or on-going medical care or the day of discharge from the hospital. time_frame: Up to 24 Weeks [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04303299 | BNP | Detailed Description |
C-reactive protein (CRP) | Detailed Description | |
D-dimer | Detailed Description | |
seryl-tRNA synthetase | Detailed Description |
Subjects
- Subject Type patients
-
Number
Planned: 320
Actual: 320
- Sex male & female
- Age Group 16-100 years; adolescent; adult; elderly
Patient Inclusion Criteria
- 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
Patient Exclusion Criteria
- 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
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04303299 | ClinicalTrials.gov: US National Institutes of Health |
TH-DMS-COVID19study | - |
Trial Dates
-
Initiation Dates
Planned : 15 Jul 2020
Actual : 19 Aug 2020
-
Primary Completion Dates
Planned : 31 Dec 2021
Actual : 28 Aug 2021
-
End Dates
Planned : 31 Dec 2021
Actual : 28 Aug 2021
Other Details
- Design multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Thailand
- Focus Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
ChloroquinePrimary Drug | Oral |
-
|
Darunavir/ritonavirPrimary Drug | Oral |
-
|
FavipiravirPrimary Drug | Oral | Tablet |
HydroxychloroquinePrimary Drug | Oral |
-
|
LopinavirPrimary Drug | Oral |
-
|
Lopinavir/ritonavirPrimary Drug | Oral |
-
|
OseltamivirPrimary Drug | Oral |
-
|
RitonavirPrimary Drug | Oral |
-
|
Darunavir /ritonavir favipiravir chloroquine mod-severe
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 (Anti virus treatment)
Darunavir /ritonavir oseltamivir chloroquine mod-severe
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 (Anti virus treatment)
Darunavir and Ritonavir plus oseltamivir
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 (Anti virus treatment)
Favipiravir lopinavir /Ritonavir for mod. To severe
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 (Anti virus treatment)
Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19
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 (Anti virus treatment)
Lopinavir and Ritonavir plus Oseltamivir in mild COVID19
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 (Anti virus treatment)
Oseltamivir plus Chloroquine in Mild COVID19
Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 800 mg per day In mild COVID19 Drug: Oral (Anti virus treatment)
Conventional Qurantine
Patient who unwilling to treatment and willing to quarantine in mild COVID19
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Narumol Sawanpanyalert, M.D., M.P.H
66818424148
show details
thailandemt2019@gmail.com |
-
|
|
Subsai Kongsaengdao, M.D.
66818180890
show details
skhongsa@gmail.com |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
Assistant Professor Subsai Kongsaengdao | Bangkok | Thailand |
Rajavithi Hospital |
-
|
-
|
Trial History
Event Date | Event Type | Comment |
---|---|---|
06 Sep 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 06 Sep 2021 |
02 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
28 Aug 2021 | Status change - completed | Status changed from recruiting to completed. Updated 06 Sep 2021 |
19 Aug 2020 | Completion date | Planned End Date changed from 30 Mar 2021 to 31 Dec 2021. Updated 25 Aug 2020 |
19 Aug 2020 | Other trial event | Planned primary completion date changed from 31 Dec 2020 to 31 Dec 2021. Updated 25 Aug 2020 |
19 Aug 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 25 Aug 2020 |
17 Jun 2020 | Completion date | Planned End Date changed from 30 Nov 2020 to 30 Mar 2021. Updated 17 Jun 2020 |
17 Jun 2020 | Other trial event | Planned primary completion date changed from 31 Oct 2020 to 31 Dec 2020. Updated 17 Jun 2020 |
17 Jun 2020 | Other trial event | Planned initiation date changed from 15 Apr 2020 to 15 Jul 2020. Updated 17 Jun 2020 |
08 Apr 2020 | Other trial event | Planned number of patients changed from 80 to 320. Updated 13 Apr 2020 |
08 Apr 2020 | Other trial event | Planned initiation date changed from 15 Mar 2020 to 15 Apr 2020. Updated 13 Apr 2020 |
19 Mar 2020 | New trial record | New trial record Updated 19 Mar 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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