NCT05218356 Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
| NCT ID | NCT05218356 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Code Pharma |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-01-20 |
| Primary Completion | 2024-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2022-01-20 with a primary completion date of 2024-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Frequently Asked Questions
Who can join the NCT05218356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05218356 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05218356 currently recruiting?
Yes, NCT05218356 is actively recruiting participants. Visit ClinicalTrials.gov or contact Code Pharma to inquire about joining.
Where is the NCT05218356 trial being conducted?
This trial is being conducted at Paulo Prata, Brazil, Prado, Brazil, Casa de Pedra, Brazil, Vila Martina, Brazil and 1 additional location.
Who is sponsoring the NCT05218356 clinical trial?
NCT05218356 is sponsored by Code Pharma. The trial plans to enroll 130 participants.
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