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

Summary

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonide and Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.

Conditions

• Covid19
• SARS-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)

Sponsors & Collaborators

• Cytel Inc.

  collaborator INDUSTRY

• McMaster University

  collaborator OTHER

• Fastgrants

  collaborator UNKNOWN

• Eiger BioPharmaceuticals

  collaborator INDUSTRY

• RainWater Foundation

  collaborator UNKNOWN

• Cardresearch

  lead OTHER

Principal Investigators

• Gilmar Reis, MD,PhD. · Cardresearch - Cardiologia Assistencial e de Pesquisa

• Edward J Mills, FRCP · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-19

Primary Completion

2024-06-01

Completion

2024-07-01

Countries

• Brazil

Study Locations