Сlinical Trial of Efficacy and Safety of Prospekta in the Treatment of Post-COVID-19 Asthenia.

NCT ID: NCT05074888

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 676 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-06-08

Brief Summary

The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.

The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).

Detailed Description

Design: the multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.

The study will enroll adult patients of either gender aged 18 to 65 years after new coronavirus infection of 2019 (COVID-19) with symptoms of asthenia that appeared during or after an acute coronavirus infection (COVID-19) and persisting 4 to 12 weeks from the onset of coronavirus infection.

After the patient signs the patient information sheet and the informed consent form for participation in the study, complaints, medical history, physical examination, registration of vital signs are collected, the patient fills in the Fatigue Severity Scale (FSS) and Hospital Anxiety and Depression Scale (HADS). A six-minute walk test (6MWT) is carried out. The physician evaluates the severity of asthenia with FSS scale and records concomitant medications, co-morbidities and concurrent conditions.

If a patient meets all inclusion criteria and does not have any of the exclusion criteria at Visit 1 (Day 1), he/she is randomized to one of two groups: Group 1 - patients receive Prospekta at a dose of 1 tablet twice daily for 4 weeks; Group 2 - patients receive placebo on the study drug regimen.

The trial will use electronic patient diaries (EPD). The patient should record any possible deterioration (if applicable) in the EPD. At Visit 1 (Day 1), the physician will provide guidance on how to work with EPD, so that the patient can use it independently in the future.

At Visit 2 (Week 4 ± 3 days), the physician will collect patient's complaints, record physical examination data and vital signs as well as any changes in concurrent diseases and conditions. The patient fills out the FSS and HADS scales. A 6MWT is carried out. The physician monitors the prescribed treatment and use of concomitant medications, evaluates the safety of the study treatment and patient's compliance, filling out the diary.

The patient stops taking the study drug. At the end of the study treatment period, the patient is monitored for 4 weeks (follow-up period).

At Visit 3 (final visit, Week 8 ± 3 days), the physician collects patient's complaints, records physical examination data and vital signs, changes in concomitant diseases and conditions. The patient fills in the FSS and HADS scales. A 6MWT is carried out. The physician evaluates the safety of the study treatment, checks the completion of the diary.

During the study the patients are allowed to take medications for their chronic conditions, except for medicines listed as "Prohibited concomitant treatment".

Conditions

Post-acute COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prospekta

Tablet for oral use. 1 tablet twice daily. The tablets are taken outside of meals (between meals or 15 minutes before eating or drinking), keep the tablets in the mouth, without swallowing, until completely dissolved.

Group Type: EXPERIMENTAL

Prospekta

Intervention Type: DRUG

Oral administration.

Placebo

Tablet for oral use. Placebo using Prospekta scheme.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration.

Interventions

Prospekta

Oral administration.

Intervention Type: DRUG

Placebo

Oral administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults of either gender aged 18 to 65 years inclusive.

2. Patients within 4-12 weeks of the confirmed COVID-19 onset .

3. Symptoms of asthenia that appeared during or after an acute new coronavirus infection (COVID-19), persisting from 4 to 12 weeks from the onset of coronavirus infection.

4. Presence of asthenia (≥36 on the FSS scale).

5. Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).

6. Presence of a signed information sheet and informed consent form for participation in a clinical trial.

Exclusion Criteria

1. History / suspicion of cancer of any localization (with the exception of benign neoplasms).

2. More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).

3. Cerebrovascular diseases with the development of moderate to severe cognitive impairments.

4. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.

5. Myocardial infarction, stroke in the previous 6 months.

6. Nervous system disorders with persistent neurological impairment.

7. Autoimmune diseases.

8. Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders.

9. Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.

10. Hypersensitivity to any of the components of the study drug.

11. Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.

12. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial (for men and women with reproductive potential).

13. Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures..

14. Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.

15. Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment.

16. Participation in other clinical studies within 3 months prior to enrollment in the study.

17. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. "Immediate relative" means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).

18. Participants who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Belgorod Regional Clinical Hospital of St. Joasaph

Belgorod, , Russia

Clinical hospital "RZD-Medicine" of Chelyabinsk city

Chelyabinsk, , Russia

Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10

Ivanovo, , Russia

City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic

Izhevsk, , Russia

Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky

Kazan', , Russia

Kazan State Medical University

Kazan', , Russia

Kirov State Medical University, Hospital Therapy Department

Kirov, , Russia

Kuban State Medical University, Infectious Diseases and Phthisiopulmonology

Krasnodar, , Russia

Krasnogorsk city hospital #r 1

Krasnogorsk, , Russia

City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department

Moscow, , Russia

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, , Russia

Llc "Verum Medical"

Moscow, , Russia

Moscow State Medical and Dental University named after A.I. Evdokimov, Department of Faculty Therapy and Occupational Diseases

Moscow, , Russia

Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology

Nizhny Novgorod, , Russia

Llc "Nizhmedklinika"

Nizhny Novgorod, , Russia

City Emergency Hospital of Rostov-on-Don

Rostov-on-Don, , Russia

Ryazan State Medical University named after acad. I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine

Ryazan, , Russia

Llc "Ava-Peter"

Saint Petersburg, , Russia

LLC "Energy of Health"

Saint Petersburg, , Russia

LLC Medical center" Reavita Med SPb "

Saint Petersburg, , Russia

City polyclinic # 51

Saint Petersburg, , Russia

City Polyclinic # 34

Saint Petersburg, , Russia

Saratov State Medical University named after V. I. Razumovsky, Neurology Department named after K.N. Tretyakov

Saratov, , Russia

LLC "Scientific Medical Center for General Therapy and Pharmacology"

Stavropol, , Russia

Bashkir State Medical University, Internal Medicine Department

Ufa, , Russia

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, , Russia

Vsevolozhsk clinical interdistrict hospital

Vsevolozhsk, , Russia

LLC "Center for Medical Consulting and Research - PRACTICE"

Yaroslavl, , Russia

Clinical Hospital # 2

Yaroslavl, , Russia

Clinical Hospital # 9

Yaroslavl, , Russia

LLC "Family Clinic"

Yekaterinburg, , Russia

Central city hospital # 7

Yekaterinburg, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MMH-MAP-006

Identifier Type: -

Identifier Source: org_study_id