Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05218356

Run by

Code Pharma

People needed

130

Starts

2022-01-20

Expected to finish

2025-07-20

Last updated by the study team

2024-10-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital de Amor — Paulo Prata, Barretos/SP/BRA, Brazil (enrolling)
• Infection Control — Prado, Belo Horizonte/MG/BRA, Brazil (enrolling)
• Instituto Lobus — Casa de Pedra, Volta Redonda/RJ/BRA, Brazil (enrolling)
• A2Z Clinical — Vila Martina, Volta Redonda/RJ/BRA, Brazil (enrolling)
• Casa de Saude — Centro, Brazil (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.