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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074888
Recruitment Status : Active, not recruiting
First Posted : October 12, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

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).


Condition or disease Intervention/treatment Phase
Post-acute COVID-19 Syndrome Drug: Prospekta Drug: Placebo Phase 3

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind, placebo-controlled, parallel-group, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: 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.
Drug: Prospekta
Oral administration.

Placebo Comparator: Placebo
Tablet for oral use. Placebo using Prospekta scheme.
Drug: Placebo
Oral administration.




Primary Outcome Measures :
  1. Change in the mean FSS score. [ Time Frame: after 4 weeks of treatment ]
    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 :
  1. Change in distance of the 6-minute walk test. [ Time Frame: after 4 weeks of treatment ]
    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.

  2. Change in the severity of anxiety and depression on the HADS subscales. [ Time Frame: after 4 weeks of treatment ]

    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".


  3. Change in the mean FSS score within follow-up period. [ Time Frame: within 4 weeks of follow-up ]
    Change in mean FSS score over 4 weeks of follow-up period at the end of treatment.

  4. Change in distance of the 6-minute walk test within follow-up period. [ Time Frame: within 4 weeks of follow-up ]
    Change in distance when performing the 6-minute walk test over a 4-week follow-up period at the end of treatment.

  5. Change in the severity of anxiety and depression on the HADS subscales within follow-up period. [ Time Frame: within 4 weeks of follow-up ]
    Change in the severity of anxiety and depression on the HADS subscales over a 4-week follow-up period at the end of treatment.

  6. Changes in vital signs (pulse rate (heart rate)). [ Time Frame: Changes in vital signs aafter 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment. ]
    Based on medical records. Vital signs will be measured in a medical setting.

  7. Changes in vital signs (respiration rate (breathing rate)). [ Time Frame: Changes in vital signs aafter 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment. ]
    Based on medical records. Vital signs will be measured in a medical setting.

  8. Changes in vital signs (blood pressure). [ Time Frame: Changes in vital signs aafter 4 weeks of treatment and within 4 weeks of the follow-up period at the end of the treatment. ]
    Based on medical records. Vital signs will be measured in a medical setting.

  9. The presence and nature of of adverse events (AEs). [ Time Frame: 4 weeks of treatment and within 4 weeks of follow-up ]
    The presence and nature of adverse events, their intensity (severity), causal relationship to the study drug, outcome. Based on medical records.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074888


Locations
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Sponsors and Collaborators
Materia Medica Holding
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Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT05074888    
Other Study ID Numbers: MMH-MAP-006
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Asthenia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases