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

Primary Purpose

Post-acute COVID-19 Syndrome

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Prospekta

Placebo

About this trial

This is an interventional treatment trial for Post-acute COVID-19 Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults of either gender aged 18 to 65 years inclusive.
Patients within 4-12 weeks of the confirmed COVID-19 onset .
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.
Presence of asthenia (≥36 on the FSS scale).
Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential).
Presence of a signed information sheet and informed consent form for participation in a clinical trial.

Exclusion Criteria:

History / suspicion of cancer of any localization (with the exception of benign neoplasms).
More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4).
Cerebrovascular diseases with the development of moderate to severe cognitive impairments.
Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
Myocardial infarction, stroke in the previous 6 months.
Nervous system disorders with persistent neurological impairment.
Autoimmune diseases.
Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders.
Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
Hypersensitivity to any of the components of the study drug.
Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
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).
Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures..
Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures.
Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment.
Participation in other clinical studies within 3 months prior to enrollment in the study.
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).
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).

Sites / Locations

Belgorod Regional Clinical Hospital of St. Joasaph
Clinical hospital "RZD-Medicine" of Chelyabinsk city
LLC "Family Clinic"
Central city hospital # 7
Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10
City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic
Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky
Kazan State Medical University
Kirov State Medical University, Hospital Therapy Department
Kuban State Medical University, Infectious Diseases and Phthisiopulmonology
Krasnogorsk city hospital #r 1
City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department
Central Clinical Hospital of the Russian Academy of Sciences
Llc "Verum Medical"
Moscow State Medical and Dental University named after A.I. Evdokimov, Department of Faculty Therapy and Occupational Diseases
Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
Llc "Nizhmedklinika"
City Emergency Hospital of Rostov-on-Don
Ryazan State Medical University named after acad. I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine
Llc "Ava-Peter"
LLC "Energy of Health"
LLC Medical center" Reavita Med SPb "
City polyclinic # 51
City Polyclinic # 34
Saratov State Medical University named after V. I. Razumovsky, Neurology Department named after K.N. Tretyakov
LLC "Scientific Medical Center for General Therapy and Pharmacology"
Bashkir State Medical University, Internal Medicine Department
Ulyanovsk Regional Clinical Hospital
Vsevolozhsk clinical interdistrict hospital
LLC "Center for Medical Consulting and Research - PRACTICE"
Clinical Hospital # 2
Clinical Hospital # 9

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prospekta

Placebo

Arm Description

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.

Tablet for oral use. Placebo using Prospekta scheme.

Outcomes

Primary Outcome Measures

Change in the mean FSS score.

Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. Based on medical records.1 indicates "strongly disagree" and 7 indicates "strongly agree."

Secondary Outcome Measures

Change in distance of the 6-minute walk test.

Change in distance when performing the 6-minute walk test after 4 weeks of treatment. The test is carried out with the aim of objectively assessing the patient's physical tolerance. The patient should walk the maximum possible distance for himself at his own pace on a flat surface in 6 minutes.

Change in the severity of anxiety and depression on the HADS subscales.

Hospital Anxiety and Depression Scale (HADS). Change in the severity of anxiety and depression on the HADS subscales after 4 weeks of treatment. The scale is composed of 14 statements serving 2 subscales: "anxiety" (odd items - 1, 3, 5, 7, 9, 11, 13) and "depression" (even items - 2, 4, 6, 8, 10, 12 , 14). Each statement corresponds to 4 answer options, reflecting the gradation of the severity of the sign and coded according to the increase in the severity of the symptom from 0 (no) to 3 (maximum severity). When interpreting the results, the total indicator for each subscale is taken into account, while there are 3 areas of its values: 0-7 - "norm" (absence of reliably expressed symptoms of anxiety and depression); 8-10 - "subclinical anxiety / depression"; 11 and above - "clinical anxiety / depression".

Change in the mean FSS score within follow-up period.

Change in mean FSS score over 4 weeks of follow-up period at the end of treatment.

Change in distance of the 6-minute walk test within follow-up period.

Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment.

Change in the severity of anxiety and depression on the HADS subscales within follow-up period.

Change in the severity of anxiety and depression on the HADS subscales over a 4-week follow-up period at the end of treatment.

Changes in vital signs (pulse rate (heart rate)).

Based on medical records. Vital signs will be measured in a medical setting.

Changes in vital signs (respiration rate (breathing rate)).

Based on medical records. Vital signs will be measured in a medical setting.

Changes in vital signs (blood pressure).

Based on medical records. Vital signs will be measured in a medical setting.

The presence and nature of of adverse events (AEs).

The presence and nature of adverse events, their intensity (severity), causal relationship to the study drug, outcome. Based on medical records.

Full Information

NCT ID

NCT05074888

First Posted

October 5, 2021

Last Updated

January 20, 2023

Sponsor

Materia Medica Holding

1. Study Identification

Unique Protocol Identification Number

NCT05074888

Brief Title

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

Official Title

A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 15, 2021 (Actual)

Primary Completion Date

June 8, 2022 (Actual)

Study Completion Date

June 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Materia Medica Holding

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-acute COVID-19 Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

double-blind, placebo-controlled, parallel-group, randomized

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

680 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prospekta

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Tablet for oral use. Placebo using Prospekta scheme.

Intervention Type

Drug

Intervention Name(s)

Prospekta

Intervention Description

Oral administration.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration.

Primary Outcome Measure Information:

Title

Change in the mean FSS score.

Description

Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. Based on medical records.1 indicates "strongly disagree" and 7 indicates "strongly agree."

Time Frame

after 4 weeks of treatment

Secondary Outcome Measure Information:

Title

Change in distance of the 6-minute walk test.

Description

Time Frame

after 4 weeks of treatment

Title

Change in the severity of anxiety and depression on the HADS subscales.

Description

Time Frame

after 4 weeks of treatment

Title

Change in the mean FSS score within follow-up period.

Description

Change in mean FSS score over 4 weeks of follow-up period at the end of treatment.

Time Frame

within 4 weeks of follow-up

Title

Change in distance of the 6-minute walk test within follow-up period.

Description

Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment.

Time Frame

within 4 weeks of follow-up

Title

Change in the severity of anxiety and depression on the HADS subscales within follow-up period.

Description

Change in the severity of anxiety and depression on the HADS subscales over a 4-week follow-up period at the end of treatment.

Time Frame

within 4 weeks of follow-up

Title

Changes in vital signs (pulse rate (heart rate)).

Description

Based on medical records. Vital signs will be measured in a medical setting.

Time Frame

after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.

Title

Changes in vital signs (respiration rate (breathing rate)).

Description

Based on medical records. Vital signs will be measured in a medical setting.

Time Frame

after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.

Title

Changes in vital signs (blood pressure).

Description

Based on medical records. Vital signs will be measured in a medical setting.

Time Frame

after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.

Title

The presence and nature of of adverse events (AEs).

Description

The presence and nature of adverse events, their intensity (severity), causal relationship to the study drug, outcome. Based on medical records.

Time Frame

4 weeks of treatment and within 4 weeks of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults of either gender aged 18 to 65 years inclusive. Patients within 4-12 weeks of the confirmed COVID-19 onset . 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. Presence of asthenia (≥36 on the FSS scale). Patients who agreed to use a reliable method of contraception during the study (for men and women with reproductive potential). Presence of a signed information sheet and informed consent form for participation in a clinical trial. Exclusion Criteria: History / suspicion of cancer of any localization (with the exception of benign neoplasms). More than 75% of lung tissue damage during the period of COVID-19 disease (CT 4). Cerebrovascular diseases with the development of moderate to severe cognitive impairments. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg. Myocardial infarction, stroke in the previous 6 months. Nervous system disorders with persistent neurological impairment. Autoimmune diseases. Decompensated diseases of the cardiovascular system, liver, kidney, gastrointestinal tract, and metabolic, respiratory, endocrine or hematological diseases, peripheral vascular disorders. Any severe comorbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial. Hypersensitivity to any of the components of the study drug. Hereditary lactose intolerance, lactose malabsorption, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. 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). Patients, who, from the investigator's point of view, will not comply with study observation requirements or study drug administration procedures.. Prior history of mental illness, alcoholism or drug abuse, that the investigator's opinion, will interfere with successful study procedures. Use of any medications listed in "Prohibited concomitant treatment" within 1 week before enrollment. Participation in other clinical studies within 3 months prior to enrollment in the study. 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). 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).

Facility Information:

Facility Name

Belgorod Regional Clinical Hospital of St. Joasaph

City

Belgorod

ZIP/Postal Code

308007

Country

Russian Federation

Facility Name

Clinical hospital "RZD-Medicine" of Chelyabinsk city

City

Chelyabinsk

ZIP/Postal Code

454000

Country

Russian Federation

Facility Name

LLC "Family Clinic"

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Central city hospital # 7

City

Ekaterinburg

ZIP/Postal Code

620137

Country

Russian Federation

Facility Name

Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10

City

Ivanovo

ZIP/Postal Code

153025

Country

Russian Federation

Facility Name

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

City

Izhevsk

ZIP/Postal Code

426063

Country

Russian Federation

Facility Name

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

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Kazan State Medical University

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Kirov State Medical University, Hospital Therapy Department

City

Kirov

ZIP/Postal Code

610027

Country

Russian Federation

Facility Name

Kuban State Medical University, Infectious Diseases and Phthisiopulmonology

City

Krasnodar

ZIP/Postal Code

350063

Country

Russian Federation

Facility Name

Krasnogorsk city hospital #r 1

City

Krasnogorsk

ZIP/Postal Code

143408

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

115516

Country

Russian Federation

Facility Name

Central Clinical Hospital of the Russian Academy of Sciences

City

Moscow

ZIP/Postal Code

117593

Country

Russian Federation

Facility Name

Llc "Verum Medical"

City

Moscow

ZIP/Postal Code

119285

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology

City

Nizhny Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

Llc "Nizhmedklinika"

City

Nizhny Novgorod

ZIP/Postal Code

603159

Country

Russian Federation

Facility Name

City Emergency Hospital of Rostov-on-Don

City

Rostov-on-Don

ZIP/Postal Code

344068

Country

Russian Federation

Facility Name

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

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Llc "Ava-Peter"

City

Saint Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

LLC "Energy of Health"

City

Saint Petersburg

ZIP/Postal Code

194156

Country

Russian Federation

Facility Name

LLC Medical center" Reavita Med SPb "

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

City polyclinic # 51

City

Saint Petersburg

ZIP/Postal Code

196211

Country

Russian Federation

Facility Name

City Polyclinic # 34

City

Saint Petersburg

ZIP/Postal Code

197198

Country

Russian Federation

Facility Name

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

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

LLC "Scientific Medical Center for General Therapy and Pharmacology"

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Bashkir State Medical University, Internal Medicine Department

City

Ufa

ZIP/Postal Code

450008

Country

Russian Federation

Facility Name

Ulyanovsk Regional Clinical Hospital

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

Vsevolozhsk clinical interdistrict hospital

City

Vsevolozhsk

ZIP/Postal Code

188643

Country

Russian Federation

Facility Name

LLC "Center for Medical Consulting and Research - PRACTICE"

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Clinical Hospital # 2

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Clinical Hospital # 9

City

Yaroslavl

ZIP/Postal Code

150042

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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