Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms

PHASE3RecruitingINTERVENTIONAL
Enrollment

7,819

Participants

Timeline

Start Date

January 19, 2021

Primary Completion Date

June 1, 2024

Study Completion Date

July 1, 2024

Conditions
Covid19SARS-Associated Coronavirus
Interventions
DIETARY_SUPPLEMENT

Spirulin Platensis

Two tablets every 12 hours since randomization through day 09 following randomization

DRUG

Budesonide Powder

"One Fluvoxamine tablet every 12 hours since randomization through day 09. PLUS~01 Budesonide powder (inhalation) every 12 hours since randomization through day 09."

DRUG

Fluoxetine 20 MG

"Two Fluoxetine tablets every day starting just after randomization through day 07.~PLUS~01 Budesonide powder (inhalation) every 12 hours since randomization through day 07."

DRUG

Placebo

"Placebo oral tablets (10-day schedule):~Matching tablets started after randomization using the dosing regimen of 01 tablet every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule)~PLUS~Placebo Inhalation Therapy:~One dosing (inhalation puff) right after randomization (Day 0) followed by one puff BID for the following 09 days~OR~Paracetamol (07-day schedule - active comparator):~Paracetamol 500 mg tablets started after randomization using the dosing regimen of 01 tablet BID starting at Rand. Day (Day 0) until end of Day 06 (total of 07 days schedule - ANTICOV Arm)~OR~Matching tablets started after randomization using the dosing regimen of 02 tablets every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule)"

Trial Locations (12)

30150240

RECRUITING

CARDRESEARCH - Cardiologia Assistencial e de Pesquisa, Belo Horizonte

30240528

RECRUITING

City of Ibirité, Ibirité

32215000

RECRUITING

Hospital e Maternidade Santa Rita, Contagem

32550770

RECRUITING

City of Betim, Betim

33105160

RECRUITING

City of Santa Luzia, Santa Luzia

34000000

RECRUITING

City of Nova Lima, Nova Lima

35400000

RECRUITING

Universidade Federal de Ouro Preto, Ouro Preto

35.460-000

NOT_YET_RECRUITING

City of Brumadinho, Brumadinho

35010-000

RECRUITING

City of Governador Valadares, Governador Valadares

32900-000

RECRUITING

City of Igarapé, Igarapé

39.408-007

RECRUITING

Centro Universitário FIPMOC, Montes Claros

35700-000

RECRUITING

City of Sete Lagoas, Sete Lagoas

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Cytel Inc.

INDUSTRY

collaborator

McMaster University

OTHER

collaborator

Fastgrants

UNKNOWN

collaborator

Eiger BioPharmaceuticals

INDUSTRY

collaborator

RainWater Foundation

UNKNOWN

lead

Cardresearch

OTHER

NCT04727424 - Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms | Biotech Hunter | Biotech Hunter