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Trial record 1 of 1 for:    NCT04930861
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Study of Codivir in Patients With COVID-19 (Codivir)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04930861
Recruitment Status : Completed
First Posted : June 18, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Code Pharma

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Covid19 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 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Study of Codivir in Outpatients With COVID-19
Actual Study Start Date : March 29, 2021
Actual Primary Completion Date : May 27, 2021
Actual Study Completion Date : August 9, 2021

Arm Intervention/treatment
Experimental: Covidir
Patient (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.
Drug: Covidir injections
administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
Other Name: Experimental drug administration

Diagnostic Test: One Step Test
rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
Other Name: Covid-19 test

Diagnostic Test: IgM and IgG dosage
blood collection for dosage of Anti SARS-CoV-2 antibodies.
Other Name: Blood test

Diagnostic Test: RT-PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
Other Name: Covid-19 test

Diagnostic Test: Screening 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.
Other Name: Blood test

Diagnostic Test: ECG
12-lead electrocardiogram with report.
Other Name: Electrocardiogram

Diagnostic Test: Medical evaluation
evaluation by the principal investigator or assistant physician with a complete physical examination.
Other Name: Physical examination

Diagnostic Test: NEWS-2 score
assessment of the participant by the NEWS-2 score.

Diagnostic Test: WHO score
assessment of the participant by the score of the World Health Organization.




Primary Outcome Measures :
  1. Incidence and severity of adverse events related to the investigational product. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28. [ Time Frame: up to 28 days ]
  2. Clinical evolution according to NEWS2 score between admission and days 10 and 28. [ Time Frame: up to 28 days ]
  3. RT-PCR negative. [ Time Frame: up to 28 days ]
  4. Evolution of IgM & IgG Anti-SARS-CoV-2. [ Time Frame: up to 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 60 years;
  2. Male or female;
  3. SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
  4. Mild or moderate COVID-19:

    • The oxygen saturation in room air >93%;
    • <30 breaths per minute;
  5. No signs of hemodynamic decompensation.
  6. Absence of pregnancy in women of childbearing age.
  7. Able to understand and comply with the requirements of the protocol.
  8. Consent to participate

Exclusion Criteria:

  1. Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
  2. Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
  3. 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;
  4. Body mass index less than 19.9 or greater than 35;
  5. 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;
  6. Concomitant HIV, HBV or HCV infection.
  7. Pregnancy or lactation;
  8. Participation in another clinical trial in the 12 months preceding inclusion;
  9. Anti-COVID-19 vaccination at any time;
  10. Vaccination for any other infection in the 4 weeks prior to inclusion;
  11. Any condition that increases the risk of participating in the study, in the opinion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04930861


Locations
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Brazil
Hospital Vera Cruz S A (Campinas-SP)
Campinas, State Of São Paulo, Brazil, 13092-108
Sponsors and Collaborators
Code Pharma
Investigators
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Study Director: Eynat Finkelshtein Code Pharma
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Responsible Party: Code Pharma
ClinicalTrials.gov Identifier: NCT04930861    
Other Study ID Numbers: 20-01-ZM
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Code Pharma:
Corona
Coronavirus
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases