Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Codivir treatment | Experimental | 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days |
|
| Placebo treatment | Placebo Comparator | Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covidir injections | Drug | administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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):
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Amor | Recruiting | Paulo Prata | Barretos/SP/BRA | 147844-000 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
the study is a double-blind study: neither the participants nor the investigators will be aware of arm allocation of each study participant. Blindness is important to avoid bias. Monitoring and reporting of the success of blindness are important for the reader's confidence of the trial results. Groups should be marked by capital letter and blindness should maintain throughout the study.
|
| Quantitative PCR SARS-CoV-2 | Diagnostic Test | detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique. |
|
| IgM and IgG dosage | Diagnostic Test | lood collection for dosage of Anti SARS-CoV-2 antibodies. |
|
| Screening Blood tests | Diagnostic 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. |
|
| Electrocardiogram | Diagnostic Test | valuation by the principal investigator or assistant physician with a complete physical examination |
|
|
| NEWS-2 score | Other | assessment of the participant by the NEWS-2 score. |
|
| WHO score | Other | assessment of the participant by the score of the World Health Organization. |
|
| Physical examination | Other | evaluation by the principal investigator or assistant physician |
|
| COVID-19-Related Symptoms assessment | Other | will be completed by the study staff member based on patient status and answers. |
|
| 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 | up to 28 days |
| RT-PCR viral load | Time to decreased RT-PCR viral load in the treatment group in comparison with Placebo | 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 | up to 28 days |
| Infection Control | Recruiting | Prado | Belo Horizonte/MG/BRA | 30.110-063 | Brazil |
|
| Instituto Lobus | Recruiting | Casa de Pedra | Volta Redonda/RJ/BRA | 27253-003 | Brazil |
|
| A2Z Clinical | Recruiting | Vila Martina | Volta Redonda/RJ/BRA | 13271-130 | Brazil |
|
| Casa de Saude | Recruiting | Centro | 13015-240 | Brazil |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
Not provided
Not provided