Evaluating Codivir for hospitalized patients with moderate COVID-19

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

This study is testing if a new medication called Codivir can help hospitalized adults with moderate COVID-19 feel better and recover faster compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Code Pharma (Industry-sponsored)
• Locations: 5 sites (Paulo Prata, Barretos/SP/BRA and 4 other locations)
• Trial ID: NCT05218356 on ClinicalTrials.gov

What this trial studies

This is a double-blind, multicentre, multinational clinical trial assessing the safety and preliminary efficacy of Codivir in 130 hospitalized adults with moderate COVID-19 symptoms. Participants will receive either Codivir or a placebo alongside standard care, with treatment starting in the hospital and continuing at home for up to 7 days. Follow-up will occur via phone and telemedicine for 28 days to monitor symptoms and collect data on adverse events. The study aims to determine the effectiveness of Codivir in improving patient outcomes during hospitalization and recovery.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 18 to 75 with confirmed moderate COVID-19 symptoms.

Not a fit: Patients requiring oxygen supplementation beyond nasal prongs or those with severe respiratory distress may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve recovery times and outcomes for patients with moderate COVID-19.

How similar studies have performed: Other studies have explored treatments for COVID-19, but the specific use of Codivir in this context is novel.

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.

Where this trial is running

Paulo Prata, Barretos/SP/BRA and 4 other locations

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

Conditions COVID-19