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Trial record 1 of 1 for:    NCT05218356
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Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT05218356
Recruitment Status : Recruiting
First Posted : February 1, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Covidir injections Diagnostic Test: Quantitative PCR SARS-CoV-2 Diagnostic Test: IgM and IgG dosage Diagnostic Test: Screening Blood tests Diagnostic Test: Electrocardiogram Other: NEWS-2 score Other: WHO score Other: Physical examination Other: COVID-19-Related Symptoms assessment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19
Actual Study Start Date : January 20, 2022
Estimated Primary Completion Date : January 20, 2023
Estimated Study Completion Date : July 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Codivir treatment
20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days
Drug: Covidir injections
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)
Other Name: Experimental drug administration

Diagnostic Test: Quantitative PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

Diagnostic Test: IgM and IgG dosage
lood collection for dosage of Anti SARS-CoV-2 antibodies.

Diagnostic Test: Screening Blood tests
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.

Diagnostic Test: Electrocardiogram
valuation by the principal investigator or assistant physician with a complete physical examination
Other Name: ECG

Other: NEWS-2 score
assessment of the participant by the NEWS-2 score.

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

Other: Physical examination
evaluation by the principal investigator or assistant physician

Other: COVID-19-Related Symptoms assessment
will be completed by the study staff member based on patient status and answers.

Placebo Comparator: Placebo treatment
Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days
Drug: Covidir injections
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)
Other Name: Experimental drug administration

Diagnostic Test: Quantitative PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.

Diagnostic Test: IgM and IgG dosage
lood collection for dosage of Anti SARS-CoV-2 antibodies.

Diagnostic Test: Screening Blood tests
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.

Diagnostic Test: Electrocardiogram
valuation by the principal investigator or assistant physician with a complete physical examination
Other Name: ECG

Other: NEWS-2 score
assessment of the participant by the NEWS-2 score.

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

Other: Physical examination
evaluation by the principal investigator or assistant physician

Other: COVID-19-Related Symptoms assessment
will be completed by the study staff member based on patient status and answers.




Primary Outcome Measures :
  1. Change in World Health Organization Ordinal Scale for clinical improvement [ Time Frame: 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 :
  1. Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo). [ Time Frame: 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

  2. adverse events [ Time Frame: up to 28 days ]
    Incidence and severity of adverse events related to the investigational product in the treatment group in comparison with Placebo

  3. RT-PCR viral load [ Time Frame: up to 28 days ]
    Time to decreased RT-PCR viral load in the treatment group in comparison with Placebo

  4. IgM & IgG anti-SARS-CoV-2 [ Time Frame: up to 28 days ]
    Evolution of IgM & IgG anti-SARS-CoV-2 in the treatment group in comparison with Placebo



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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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):

    • 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.

Exclusion Criteria:

  • 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.

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): NCT05218356


Locations
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South Africa
Worthwhile Clinical Trials, Netcare Lakeview Hospital Recruiting
Benoni, South Africa, 1500
Contact: Dr NJ Hussen Hussen, Dr    +27 (0)11 4221928    drnazreen@wwct.co.za   
Contact: Shamima Babooda, B.sc       shamima@wwct.co.za   
Principal Investigator: Dr NJ Hussen Hussen, Dr         
Ahmed Al-Kadi Private Hospital, Recruiting
Durban, South Africa
Contact: Moosa Suleman, Dr    +27 31 492 3498/ 083 786 3007    msulemanmd@gmail.com   
Contact: Aadil Munga, B.sc       aadilmunga@gmail.com   
Principal Investigator: Moosa Suleman, Dr         
Sponsors and Collaborators
Code Pharma
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Responsible Party: Code Pharma
ClinicalTrials.gov Identifier: NCT05218356    
Other Study ID Numbers: CP-21-01
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
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
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