Actively Recruiting
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
Led by Code Pharma · Updated on 2024-10-02
130
Participants Needed
5
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a double-blind, multicentre, multinational study to evaluate the safety and collect preliminary efficacy data of Codivir drug product in 130 hospitalized adults with moderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smell or taste) onset must be within 7 days prior enrolment. Treatment will begin in the hospital, participants will be discharged according to medical decision and continue the treatment until to Day 7 at home and followed up to day 28.
CONDITIONS
Official Title
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male or female
- Confirmed SARS-CoV-2 infection by RT-PCR test
- Moderate hospitalized COVID-19 meeting at least two of the following: evidence of lower respiratory disease (cough, fever, difficulty breathing or imaging), oxygen saturation below 93% on room air, or less than 30 breaths per minute
- No signs of hemodynamic decompensation
- Women of childbearing age must not be pregnant
- Ability to understand and follow study protocol
- Consent to participate and to use effective contraception from consent signing through 30 days after study
You will not qualify if you...
- Use of oxygen supplementation beyond nasal prongs, nasal intermittent positive pressure ventilation, or high flow nasal cannula
- Positive RT-PCR test more than 72 hours before enrollment
- Symptom onset more than 7 days before enrollment
- Use of drugs under clinical investigation in last 30 days
- Body mass index under 19.9 or over 35
- Serious infections, active cancer, autoimmune diseases, or liver, kidney, heart failure, or other systemic diseases preventing participation
- HIV, HBV, or HCV infection
- Pregnancy or lactation
- Vaccination for any infection within 4 weeks before enrollment
- Any condition increasing risk of participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hospital de Amor
Paulo Prata, Barretos/SP/BRA, Brazil, 147844-000
Actively Recruiting
2
Infection Control
Prado, Belo Horizonte/MG/BRA, Brazil, 30.110-063
Actively Recruiting
3
Instituto Lobus
Casa de Pedra, Volta Redonda/RJ/BRA, Brazil, 27253-003
Actively Recruiting
4
A2Z Clinical
Vila Martina, Volta Redonda/RJ/BRA, Brazil, 13271-130
Actively Recruiting
5
Casa de Saude
Centro, Brazil, 13015-240
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here