Clinical Trial of Efficacy and Safety of Raphamin in the Treatment of Coronavirus Disease 2019 in Outpatients

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter double-blind placebo-controlled parallel-group randomized clinical trial of efficacy and safety of Raphamin in the treatment of coronavirus disease 2019 in outpatients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

Criteria

Inclusion Criteria:

1. Male and female patients aged 18-75 years old.

2. Diagnosis of new coronavirus infection COVID-19 based on medical examination: axillary temperature >37.5°C, upper respiratory infection symptoms, SpO2 ≥ 95%, no symptoms of moderate or severe forms.

3. The minimal baseline score for COVID-19-related symptoms defined as follows: at least two symptoms with a score of 2 or higher, with the exception of taste and smell where subjects may have a score of 1 or higher, and the absence of shortness of breath (difficulty breathing).

4. Positive rapid test for for SARS-CoV-2 (COVID-19).

5. The first 24 hours from the disease onset.

6. Patients giving their consent to use reliable contraception during the study.

7. Signed patient information sheet (informed consent form).

Exclusion Criteria:

1. Moderate and severe COVID-19.

2. The first four weeks after any vaccination/revaccination, including against COVID-19, influenza, pneumococcal and other infections.

3. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.).

4. Patients requiring medications prohibited within the study.

5. Medical history of or previously diagnosed primary and secondary immunodeficiency.

6. Medical history/suspicion of oncology of any localization (except for benign neoplasms).

7. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical study.

8. Malabsorption syndrome, including congenital or acquired lactase or disaccharidase deficiency, galactosemia.

9. Allergy/ hypersensitivity to any of the components of the medications used in the treatment.

10. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.

11. Use of medications listed in "Prohibited concomitant therapy" within 4 weeks before the study entry.

12. Patients who, from the investigator's point of view, will fail to comply with the requirements of the trial or with the intake regimen of the study drugs.

13. Medical history of mental diseases, alcoholism or drug abuse which, according to the investigator's opinion, will interfere with the study procedures.

14. Participation in other clinical trials within 3 months prior to enrollment in this study.

15. The patient is related to the study center staff directly involved in the trial or is the immediate relative of the investigator. 'Immediate relative' means husband/wife, parents, children, brother/sister regardless of whether they are natural or adopted.

16. The patient works for OOO "NPF "MATERIA MEDICA HOLDING" i.e. is the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family.