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

NCT05074888 | Completed Phase 3 Results

• 1 other identifier: MMH-MAP-006
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 32

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).

Conditions

Post-acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in the Mean FSS Score.

  Fatigue Severity Scale (FSS). Change in the mean FSS score after 4 weeks of treatment. The total score of the scale, which consists of 9 questions, varies between 9-63. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period. A total of 36 points and above indicate fatigue. A higher score is indicated high level of fatigue.

  after 4 weeks of treatment

Secondary Outcomes (14)

• Change in Distance of the 6-minute Walk Test.

  after 4 weeks of treatment

• Change in the Severity of Anxiety on the HADS Subscale.

  after 4 weeks of treatment

• Change in the Severity of Depression on the HADS Subscale.

  after 4 weeks of treatment

• Change in the Mean FSS Score Within Follow-up Period.

  after 4 weeks of treatment and after 4 weeks of follow-up at week 8

• Change in Distance of the 6-minute Walk Test Within Follow-up Period.

  after 4 weeks of treatment and after 4 weeks of follow-up at week 8

Study Arms (2)

Prospekta

EXPERIMENTAL

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.

Drug: Prospekta

Placebo

PLACEBO COMPARATOR

Tablet for oral use. Placebo using Prospekta scheme.

Drug: Placebo

Interventions

Prospekta DRUG

Oral administration.

Prospekta

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (32)

Belgorod Regional Clinical Hospital of St. Joasaph

Belgorod, 308007, Russia

Location

Clinical hospital "RZD-Medicine" of Chelyabinsk city

Chelyabinsk, 454000, Russia

Location

Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10

Ivanovo, 153025, Russia

Location

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

Izhevsk, 426063, Russia

Location

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

Kazan', 420012, Russia

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Kirov State Medical University, Hospital Therapy Department

Kirov, 610027, Russia

Location

Kuban State Medical University, Infectious Diseases and Phthisiopulmonology

Krasnodar, 350063, Russia

Location

Krasnogorsk city hospital #r 1

Krasnogorsk, 143408, Russia

Location

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

Moscow, 115516, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

Llc "Verum Medical"

Moscow, 119285, Russia

Location

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

Moscow, 127473, Russia

Location

Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology

Nizhny Novgorod, 603005, Russia

Location

Llc "Nizhmedklinika"

Nizhny Novgorod, 603159, Russia

Location

City Emergency Hospital of Rostov-on-Don

Rostov-on-Don, 344068, Russia

Location

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

Ryazan, 390026, Russia

Location

Llc "Ava-Peter"

Saint Petersburg, 191014, Russia

Location

LLC "Energy of Health"

Saint Petersburg, 194156, Russia

Location

LLC Medical center" Reavita Med SPb "

Saint Petersburg, 194354, Russia

Location

City polyclinic # 51

Saint Petersburg, 196211, Russia

Location

City Polyclinic # 34

Saint Petersburg, 197198, Russia

Location

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

Saratov, 410012, Russia

Location

LLC "Scientific Medical Center for General Therapy and Pharmacology"

Stavropol, 355000, Russia

Location

Bashkir State Medical University, Internal Medicine Department

Ufa, 450008, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

Location

Vsevolozhsk clinical interdistrict hospital

Vsevolozhsk, 188643, Russia

Location

LLC "Center for Medical Consulting and Research - PRACTICE"

Yaroslavl, 150003, Russia

Location

Clinical Hospital # 2

Yaroslavl, 150030, Russia

Location

Clinical Hospital # 9

Yaroslavl, 150042, Russia

Location

LLC "Family Clinic"

Yekaterinburg, 620109, Russia

Location

Central city hospital # 7

Yekaterinburg, 620137, Russia

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, parallel-group, randomized

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 12, 2021
• Study Start: October 15, 2021
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2023-01

Locations

RU (32)