Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2020

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 THDMS-COVID-19
  • Most Recent Events

    • 08 Apr 2020 Planned number of patients changed from 80 to 320.
    • 08 Apr 2020 Planned initiation date changed from 15 Mar 2020 to 15 Apr 2020.
    • 19 Mar 2020 New trial record

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

Death

description: Any death
time_frame: Up to 24 weeks

Recovery rate

description: Normal pulmonary function
time_frame: Up to 24 weeks

ventilator dependent

description: Number of day with ventilator assistant
time_frame: Up to 24 weeks

Acute Respiratory Distress Syndrome Rate

description: Number of patient developed new ARDS
time_frame: Up to 24 weeks

Acute Respiratory Distress Syndrome Recovery rate

description: Acute Respiratory Distress Syndrome Recovery rate
time_frame: Up to 24 weeks [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 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 Apr 2020

  • Primary Completion Dates

    Planned : 31 Oct 2020

  • End Dates

    Planned : 30 Nov 2020

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
thailandemt2019@gmail.com
show details
-
Subsai Kongsaengdao, M.D.
66818180890
skhongsa@gmail.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Assistant Professor Subsai Kongsaengdao Bangkok Thailand
Rajavithi Hospital
-
-

Trial History

Event Date Event Type Comment
13 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 13 Apr 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

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
Back to top