Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19
- Conditions
- COVID-19
- Interventions
- Diagnostic Test: Quantitative PCR SARS-CoV-2Diagnostic Test: IgM and IgG dosageDiagnostic Test: Screening Blood testsDiagnostic Test: ElectrocardiogramOther: NEWS-2 scoreOther: WHO scoreOther: Physical examinationOther: COVID-19-Related Symptoms assessment
- Registration Number
- NCT05218356
- Lead Sponsor
- Code Pharma
- Brief 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
-
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%
- <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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Codivir treatment Covidir injections 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment Quantitative PCR SARS-CoV-2 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment Physical examination 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment Screening Blood tests Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment Electrocardiogram Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment COVID-19-Related Symptoms assessment Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment NEWS-2 score Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment NEWS-2 score 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment Physical examination Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment Electrocardiogram 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment COVID-19-Related Symptoms assessment 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment IgM and IgG dosage Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment WHO score Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment IgM and IgG dosage 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment Screening Blood tests 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Codivir treatment WHO score 20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment Quantitative PCR SARS-CoV-2 Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days Placebo treatment Covidir injections Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days
- Primary Outcome Measures
Name Time Method Change in World Health Organization Ordinal Scale for clinical improvement 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
- Secondary Outcome Measures
Name Time Method adverse events up to 28 days Incidence and severity of adverse events related to the investigational product in the treatment group in comparison with Placebo
RT-PCR viral load up to 28 days Time to decreased RT-PCR viral load in the treatment group in comparison with Placebo
IgM & IgG anti-SARS-CoV-2 up to 28 days Evolution of IgM \& IgG anti-SARS-CoV-2 in the treatment group in comparison with Placebo
Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo). up to 28 days 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
Trial Locations
- Locations (5)
Hospital de Amor
🇧🇷Paulo Prata, Barretos/SP/BRA, Brazil
Infection Control
🇧🇷Prado, Belo Horizonte/MG/BRA, Brazil
Instituto Lobus
🇧🇷Casa de Pedra, Volta Redonda/RJ/BRA, Brazil
A2Z Clinical
🇧🇷Vila Martina, Volta Redonda/RJ/BRA, Brazil
Casa de Saude
🇧🇷Centro, Brazil