Study of Codivir in Patients With COVID-19 (Codivir)
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|ClinicalTrials.gov Identifier: NCT04930861|
Recruitment Status : Completed
First Posted : June 18, 2021
Last Update Posted : November 2, 2021
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|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)|
|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|
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.
- Incidence and severity of adverse events related to the investigational product. [ Time Frame: 28 days ]
- Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28. [ Time Frame: up to 28 days ]
- Clinical evolution according to NEWS2 score between admission and days 10 and 28. [ Time Frame: up to 28 days ]
- RT-PCR negative. [ Time Frame: up to 28 days ]
- Evolution of IgM & IgG Anti-SARS-CoV-2. [ Time Frame: up to 28 days ]
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
|Hospital Vera Cruz S A (Campinas-SP)|
|Campinas, State Of São Paulo, Brazil, 13092-108|
|Study Director:||Eynat Finkelshtein||Code Pharma|