Clinical trial NCT05074888: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-acute COVID-19 Syndrome
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2021-10-12
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, placebo-controlled, parallel-group, randomized
Primary purpose: TREATMENT

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".

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).

Primary outcomes:
measure: Change in the Mean FSS Score.
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Change in Distance of the 6-minute Walk Test.
timeFrame: after 4 weeks of treatment
measure: Change in the Severity of Anxiety on the HADS Subscale.
timeFrame: after 4 weeks of treatment
measure: Change in the Severity of Depression on the HADS Subscale.
timeFrame: after 4 weeks of treatment
measure: Change in the Mean FSS Score Within Follow-up Period.
timeFrame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
measure: Change in Distance of the 6-minute Walk Test Within Follow-up Period.
timeFrame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
measure: Change in the Severity of Anxiety on the HADS Subscales Within Follow-up Period.
timeFrame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
measure: Change in the Severity of Depression on the HADS Subscales Within Follow-up Period.
timeFrame: after 4 weeks of treatment and after 4 weeks of follow-up at week 8
measure: Changes in Vital Signs (Pulse Rate (Heart Rate)).
timeFrame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment.
measure: Changes in Vital Signs (Respiration Rate (Breathing Rate)).
timeFrame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8)
measure: Changes in Vital Signs (Blood Pressure).
timeFrame: after 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment (Visit 1: baseline, Visit 2: after 4 weeks of treatment, and Visit 3: after 4 weeks of follow-up at week 8).
measure: Presence of Adverse Events (AEs).
timeFrame: 8 weeks
measure: The Severity of AEs.
timeFrame: 8 weeks
measure: The Outcome of AEs.
timeFrame: 8 weeks
measure: AEs Causal Relationship to the Study Drug.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Clinical Hospital of St. Joasaph
city: Chelyabinsk
country: Russian Federation
facility: Clinical hospital "RZD-Medicine" of Chelyabinsk city
city: Ekaterinburg
country: Russian Federation
facility: LLC "Family Clinic"
city: Ekaterinburg
country: Russian Federation
facility: Central city hospital # 7
city: Ivanovo
country: Russian Federation
facility: Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10
city: Izhevsk
country: Russian Federation
facility: City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic
city: Kazan
country: Russian Federation
facility: Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Kirov
country: Russian Federation
facility: Kirov State Medical University, Hospital Therapy Department
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University, Infectious Diseases and Phthisiopulmonology
city: Krasnogorsk
country: Russian Federation
facility: Krasnogorsk city hospital #r 1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named after V.M. Buyanov of the Moscow City Health Department
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: Llc "Verum Medical"
city: Moscow
country: Russian Federation
facility: Moscow State Medical and Dental University named after A.I. Evdokimov, Department of Faculty Therapy and Occupational Diseases
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Research Institute of Hygiene and Occupational Pathology
city: Nizhny Novgorod
country: Russian Federation
facility: Llc "Nizhmedklinika"
city: Rostov-on-Don
country: Russian Federation
facility: City Emergency Hospital of Rostov-on-Don
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University named after acad. I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine
city: Saint Petersburg
country: Russian Federation
facility: Llc "Ava-Peter"
city: Saint Petersburg
country: Russian Federation
facility: LLC "Energy of Health"
city: Saint Petersburg
country: Russian Federation
facility: LLC Medical center" Reavita Med SPb "
city: Saint Petersburg
country: Russian Federation
facility: City polyclinic # 51
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic # 34
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V. I. Razumovsky, Neurology Department named after K.N. Tretyakov
city: Stavropol
country: Russian Federation
facility: LLC "Scientific Medical Center for General Therapy and Pharmacology"
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University, Internal Medicine Department
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
city: Vsevolozhsk
country: Russian Federation
facility: Vsevolozhsk clinical interdistrict hospital
city: Yaroslavl
country: Russian Federation
facility: LLC "Center for Medical Consulting and Research - PRACTICE"
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital # 2
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital # 9
Study officials:
References: