Status:
RECRUITING
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
Lead Sponsor:
Code Pharma
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
eligible hospitalized participants will be recruited to the study and will receive standard of care treatments as well as Codivir or placebo, which will be administered at a dose of 20 mg SC, twice a ...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years
- Male or female
- SARS-CoV-2 infection indicated by confirmed RT-PCR test
- Moderate hospitalized COVID-19 (at least two out of three criterias below):
- Evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (X-rays)
- Oxygen saturation (SpO2) in room air \< 93%
- \<30 breaths per minute
- No signs of hemodynamic decompensation
- Absence of pregnancy in women of childbearing age
- Ability to understand and comply with the requirements of the protocol
- Consent to participate
- Consent to use at least one highly effective contraception methods (condoms, IUD, oral contraceptives) since the ICF signature and at least 30 days after the study.
Exclusion
- Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are allowed to be enrolled to the study).
- Positive RT-PCR test more than 72 hours prior to enrolment.
- Onset of symptoms more than 7 days prior to enrolment.
- Participant using drugs that are under clinical investigation in last 30 days.
- Body mass index less than 19.9 or greater than 35.
- Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study.
- Concomitant HIV, HBV or HCV infection.
- Pregnancy or lactation.
- Vaccination for any other infection in the 4 weeks prior to enrolment.
- Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05218356
Start Date
January 20 2022
End Date
July 20 2025
Last Update
October 2 2024
Active Locations (5)
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1
Hospital de Amor
Paulo Prata, Barretos/SP/BRA, Brazil, 147844-000
2
Infection Control
Prado, Belo Horizonte/MG/BRA, Brazil, 30.110-063
3
Instituto Lobus
Casa de Pedra, Volta Redonda/RJ/BRA, Brazil, 27253-003
4
A2Z Clinical
Vila Martina, Volta Redonda/RJ/BRA, Brazil, 13271-130