Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Q: Who can participate in NCT05218356?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05218356?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19 (NCT05218356) is a Phase 2 interventional studying COVID-19, sponsored by Code Pharma. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against COVID-19 and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused COVID-19 subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s, 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Covidir injections

administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)

DIAGNOSTIC_TEST

Quantitative PCR SARS-CoV-2

detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

DIAGNOSTIC_TEST

IgM and IgG dosage

lood collection for dosage of Anti SARS-CoV-2 antibodies.

DIAGNOSTIC_TEST

Screening Blood tests

omplete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides); coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin; troponin, fibrinogen,Coagulogram (TP, aPTT); D-dimer, Pregnancy test for non-sterile women.

DIAGNOSTIC_TEST

Electrocardiogram

valuation by the principal investigator or assistant physician with a complete physical examination

OTHER

NEWS-2 score

assessment of the participant by the NEWS-2 score.

OTHER

WHO score

assessment of the participant by the score of the World Health Organization.

OTHER

Physical examination

evaluation by the principal investigator or assistant physician

OTHER

COVID-19-Related Symptoms assessment

will be completed by the study staff member based on patient status and answers.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospital de Amor

Paulo Prata, Barretos/SP/BRA, Brazil

Infection Control

Prado, Belo Horizonte/MG/BRA, Brazil

Instituto Lobus

Casa de Pedra, Volta Redonda/RJ/BRA, Brazil

A2Z Clinical

Vila Martina, Volta Redonda/RJ/BRA, Brazil

Casa de Saude

Centro, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05218356), the sponsor (Code Pharma), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05218356 clinical trial studying?

Who can participate in NCT05218356?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05218356?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT05218356. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05218356. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.