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Covid19Phase 1CodivirNCT04930861

Study of Codivir in Patients With COVID-19

A Phase 1 study testing Covidir injections, One Step Test and IgM and IgG dosage in people with Covid19, run by Code Pharma at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label study to evaluate the safety and preliminary efficacy of Codivir in 12 mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Covid19
What is being tested?
Covidir injections, One Step Test and IgM and IgG dosage
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteBrazil
Study dates
29 Mar 2021to 9 Aug 2021
Phase
Phase 1
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 60 years;
  • Male or female;
  • SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
  • Mild or moderate COVID-19:
  • The oxygen saturation in room air >93%;
  • <30 breaths per minute;
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  • No signs of hemodynamic decompensation.
  • Absence of pregnancy in women of childbearing age.
  • Able to understand and comply with the requirements of the protocol.
  • Consent to participate

Who cannot join

  • Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
  • Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
  • Participants in use or expected to use within 24 hours prior to the inclusion of drugs that are under clinical investigation as a therapeutic option for the treatment of COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others) during the study period;
  • 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.
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  • Pregnancy or lactation;
  • Participation in another clinical trial in the 12 months preceding inclusion;
  • Anti-COVID-19 vaccination at any time;
  • Vaccination for any other infection in the 4 weeks prior to inclusion;
  • Any condition that increases the risk of participating in the study, in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Vera Cruz S A (Campinas-SP)

    Campinas, State of São Paulo, 13092-108

Other trials in Brazil

About this study

Official title: Phase 1 Clinical Study of Codivir in Outpatients With COVID-19

This is an open-label study to evaluate the safety and preliminary efficacy of Codivir in 12 mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion. Treatment will begin in the hospital, participants will be discharged at Day 4 and continue the treatment up to Day 10 at home and followed up to day 28.

Read the detailed description

Eligible participants who agree to participate will be submitted to safety assessments, an RT-PCR and a quick test for COVID-19. Everyone will receive the treatments indicated for their case, except for other investigational medications. Codivir will be administered in addition to these treatments at a dose of 20 mg SC twice daily for 10 days. Participants will remain hospitalized for the first 3 days.

If they have progressed well, they will continue the treatment up to Day 10 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
Covid19
Being tested
Covidir injections, One Step Test, IgM and IgG dosage, RT-PCR SARS-CoV-2, Screening blood test
Keywords
Corona, Coronavirus, COVID-19, SARS-CoV-2
Medical subject headings
COVID-19, Coronavirus Infections

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 at a dose of 20 mg twice a day subcutaneously.

  • One Step TestDiagnostic test

    Also called Covid-19 test

    rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.

  • IgM and IgG dosageDiagnostic test

    Also called Blood test

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

  • RT-PCR SARS-CoV-2Diagnostic test

    Also called Covid-19 test

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

  • Screening blood testDiagnostic test

    Also called Blood test

    complete 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; fibrinogen, Pregnancy test for non-sterile women.

  • ECGDiagnostic test

    Also called Electrocardiogram

    12-lead electrocardiogram with report.

  • Medical evaluationDiagnostic test

    Also called Physical examination

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

  • NEWS-2 scoreDiagnostic test

    assessment of the participant by the NEWS-2 score.

  • WHO scoreDiagnostic test

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

Study groups in NCT04930861
Study groupRoleWhat they receive
CovidirExperimentalPatient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
Receives: Drug: Covidir injections; Diagnostic Test: One Step Test; Diagnostic Test: IgM and IgG dosage; Diagnostic Test: RT-PCR SARS-CoV-2; Diagnostic Test: Screening blood test; Diagnostic Test: ECG; Diagnostic Test: Medical evaluation; Diagnostic Test: NEWS-2 score; Diagnostic Test: WHO score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events related to the investigational product.

    Measured: 28 days

Secondary outcomes (4)

  1. Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.

    Measured: up to 28 days

  2. Clinical evolution according to NEWS2 score between admission and days 10 and 28.

    Measured: up to 28 days

  3. RT-PCR negative.

    Measured: up to 28 days

  4. Evolution of IgM & IgG Anti-SARS-CoV-2.

    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.

  1. First posted18 Jun 2021
  2. Study start29 Mar 2021
  3. Primary completion27 May 2021
  4. Study completion9 Aug 2021

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open label study to evaluate the safety and preliminary efficacy of Codivir in 12 mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion. Treatment will begin in the hospital, participants will be discharged at Day 4 and continue the treatment up to Day 10 at home.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930861
Sponsor's protocol ID
20-01-ZM
Acronym
Codivir
Status last verified
Nov 2021
First submitted
16 Jun 2021
Last updated
2 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Covidir injections, One Step Test and IgM and IgG dosage in people with Covid19, run by Code Pharma at 1 site 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 10 inclusion and 11 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: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events related to the investigational product. (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04930861.

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 Nov 2021.

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