Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19

August 30, 2023 updated by: Code Pharma
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Benoni, South Africa, 1500
        • Recruiting
        • Worthwhile Clinical Trials, Netcare Lakeview Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr NJ Hussen Hussen, Dr
      • Durban, South Africa
        • Recruiting
        • Ahmed Al-Kadi Private Hospital,
        • Contact:
        • Contact:
        • Principal Investigator:
          • Moosa Suleman, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 28 days

Secondary Outcome Measures

Outcome Measure
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).
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
up to 28 days
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
up to 28 days
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
up to 28 days
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
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Code Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Estimated)

July 20, 2024

Study Completion (Estimated)

July 20, 2024

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 30, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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