COVID-19Phase 2NCT05218356
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
A Phase 2 study testing Covidir injections, Quantitative PCR SARS-CoV-2 and IgM and IgG dosage in people with COVID-19, run by Code Pharma at 5 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Covidir injections, Quantitative PCR SARS-CoV-2 and IgM and IgG dosage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 5 sitesBrazil
- Study dates
- 20 Jan 2022to 20 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- <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 cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Recruiting
Instituto Lobus
Casa de Pedra, Volta Redonda/RJ/BRA, 27253-003
Vicente Lopes da Silva Junior, Dr., 55 21 98122-7376, vicente.junior@unimedvr.com.br
Vicente Lopes da Silva Junior, Dr.
- Recruiting
Casa de Saude
Centro, 13015-240
Florentino Cardoso, Dr., 55 11 98906-2010, florentino.cardoso@hospitalcare.com.br
- Recruiting
Hospital de Amor
Paulo Prata, Barretos/SP/BRA, 147844-000
Cesar Mauricio da Silva, Dr., 55 17 3321-6637, cesarms.research@gmail.com
Cesar Mauricio da Silva, Dr.
- Recruiting
Infection Control
Prado, Belo Horizonte/MG/BRA, 30.110-063
Carlos Ernesto Ferreira Starling, Dr., 55 31 98791-3777, cstarling@task.com.br
Carlos Ernesto Ferreira Starling, Dr.
- Recruiting
A2Z Clinical
Vila Martina, Volta Redonda/RJ/BRA, 13271-130
Dr. Ricardo Sobhie Diaz, Dr., 55 11 99109-0445, rsdiaz@catg.com.br
Dr. Ricardo Sobhie Diaz, Dr.
About this study
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.
Read the 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 day, for 7 days. If up to medical decision of the medical staff in the site, the patient should be released before Day 7, site study team will contact the medical monitor of the study to get the instructions. Participants will be followed up to the 28th day via phone contact. The phone visit will be performed to monitor the clinical symptoms, collect adverse events and concomitant medication and provide the patient with additional instructions, if relevant.
If they have progressed well, they will continue the treatment up to Day 7 at home, receiving a nurse's home visit twice a day to administer Codivir and collect vital signs. Participants will be followed up to Day 28 by telemedicine. A doctor will call them periodically to monitor the clinical evolution, collect adverse events, concomitant medication and instruct the participants. In case of unfavorable evolution, the participants will remain hospitalized receiving the appropriate care. The investigator will decide whether or not the investigational medication will continue, considering the participant's health and well-being.
- Conditions
- COVID-19
- Being tested
- Covidir injections, Quantitative PCR SARS-CoV-2, IgM and IgG dosage, Screening Blood tests, Electrocardiogram
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covidir injectionsDrug
Also called Experimental drug administration
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)
Quantitative PCR SARS-CoV-2Diagnostic test
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
IgM and IgG dosageDiagnostic test
lood collection for dosage of Anti SARS-CoV-2 antibodies.
Screening Blood testsDiagnostic test
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.
ElectrocardiogramDiagnostic test
Also called ECG
valuation by the principal investigator or assistant physician with a complete physical examination
NEWS-2 scoreOther
assessment of the participant by the NEWS-2 score.
WHO scoreOther
assessment of the participant by the score of the World Health Organization.
Physical examinationOther
evaluation by the principal investigator or assistant physician
COVID-19-Related Symptoms assessmentOther
will be completed by the study staff member based on patient status and answers.
| Study group | Role | What they receive |
|---|---|---|
| Codivir treatment | Experimental | 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Receives: Drug: Covidir injections; Diagnostic Test: Quantitative PCR SARS-CoV-2; Diagnostic Test: IgM and IgG dosage; Diagnostic Test: Screening Blood tests; Diagnostic Test: Electrocardiogram; Other: NEWS-2 score; Other: WHO score; Other: Physical examination; Other: COVID-19-Related Symptoms assessment |
| Placebo treatment | Placebo comparator | Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Receives: Drug: Covidir injections; Diagnostic Test: Quantitative PCR SARS-CoV-2; Diagnostic Test: IgM and IgG dosage; Diagnostic Test: Screening Blood tests; Diagnostic Test: Electrocardiogram; Other: NEWS-2 score; Other: WHO score; Other: Physical examination; Other: COVID-19-Related Symptoms assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in World Health Organization Ordinal Scale for clinical improvement
change in World Health Organization Ordinal Scale for clinical improvement in the treatment group in comparison with Placebo. the scale min score - 0 and max score - 8. the higher the scores mean a worse outcome
Measured: up to 28 days
Secondary outcomes (4)
Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo).
Each symptom is scored individually using the following response options and scoring values: Items 1-10: None = 0; Mild = 1; Moderate = 2; and Severe = 3 Items 11 and 12: Not at all = 0; 1-2 times = 1; 3-4 times = 2; 5 or more times = 3 Items 13 and 14: Sense of smell/taste same as usual = 0; Sense of smell/taste less than usual = 1; No sense of smell/taste = 2. he higher the scores mean a worse outcome
Measured: up to 28 days
adverse events
Incidence and severity of adverse events related to the investigational product in the treatment group in comparison with Placebo
Measured: up to 28 days
RT-PCR viral load
Time to decreased RT-PCR viral load in the treatment group in comparison with Placebo
Measured: up to 28 days
IgM & IgG anti-SARS-CoV-2
Evolution of IgM \& IgG anti-SARS-CoV-2 in the treatment group in comparison with Placebo
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start20 Jan 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Code Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218356
- Sponsor's protocol ID
- CP-21-01
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05218356
- Acronym / sponsor ID
- CP-21-01
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Code PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 day, for 7 days. If up to medical decision of the medical staff in the site, the patient should be released before Day 7, site study team will contact the medical monitor of the study to get the instructions. Participants will be followed up to the 28th day via phone contact. The phone visit will be performed to monitor the clinical symptoms, collect adverse events and concomitant medication and provide the patient with additional instructions, if relevant.
If they have progressed well, they will continue the treatment up to Day 7 at home, receiving a nurse's home visit twice a day to administer Codivir and collect vital signs. Participants will be followed up to Day 28 by telemedicine. A doctor will call them periodically to monitor the clinical evolution, collect adverse events, concomitant medication and instruct the participants. In case of unfavorable evolution, the participants will remain hospitalized receiving the appropriate care. The investigator will decide whether or not the investigational medication will continue, considering the participant's health and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Codivir treatment | Experimental | Drug: Covidir injections, Diagnostic Test: Quantitative PCR SARS-CoV-2, Diagnostic Test: IgM and IgG dosage, Diagnostic Test: Screening Blood tests, Diagnostic Test: Electrocardiogram, Other: NEWS-2 score, Other: WHO score, Other: Physical examination, Other: COVID-19-Related Symptoms assessment20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days |
| Placebo treatment | Placebo comparator | Drug: Covidir injections, Diagnostic Test: Quantitative PCR SARS-CoV-2, Diagnostic Test: IgM and IgG dosage, Diagnostic Test: Screening Blood tests, Diagnostic Test: Electrocardiogram, Other: NEWS-2 score, Other: WHO score, Other: Physical examination, Other: COVID-19-Related Symptoms assessmentPlacebo administrated in subcutaneous (SC) injection, twice a day, for 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
- No signs of hemodynamic decompensation
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covidir injectionsAlso: Experimental drug administrationadministration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total) | Drug | Codivir treatment, Placebo treatment |
| Quantitative PCR SARS-CoV-2detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique. | Diagnostic test | Codivir treatment, Placebo treatment |
| IgM and IgG dosagelood collection for dosage of Anti SARS-CoV-2 antibodies. | Diagnostic test | Codivir treatment, Placebo treatment |
| Screening Blood testsomplete 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 | Codivir treatment, Placebo treatment |
| ElectrocardiogramAlso: ECGvaluation by the principal investigator or assistant physician with a complete physical examination | Diagnostic test | Codivir treatment, Placebo treatment |
| NEWS-2 scoreassessment of the participant by the NEWS-2 score. | Other | Codivir treatment, Placebo treatment |
| WHO scoreassessment of the participant by the score of the World Health Organization. | Other | Codivir treatment, Placebo treatment |
| Physical examinationevaluation by the principal investigator or assistant physician | Other | Codivir treatment, Placebo treatment |
| COVID-19-Related Symptoms assessmentwill be completed by the study staff member based on patient status and answers. | Other | Codivir treatment, Placebo treatment |
Primary outcome
Change in World Health Organization Ordinal Scale for clinical improvement
Time frame: up to 28 days
change in World Health Organization Ordinal Scale for clinical improvement in the treatment group in comparison with Placebo. the scale min score - 0 and max score - 8. the higher the scores mean a worse outcome
4 secondary outcomes
Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo).
Time frame: up to 28 days
adverse events
Time frame: up to 28 days
RT-PCR viral load
Time frame: up to 28 days
IgM & IgG anti-SARS-CoV-2
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Covidir injections, Quantitative PCR SARS-CoV-2 and IgM and IgG dosage in people with COVID-19, run by Code Pharma at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in World Health Organization Ordinal Scale for clinical improvement (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.