A Study to Assess the Efficacy and Safety of XC221 in Patients With Mild COVID-19

NCT04940182 | Completed Phase 3 DMC

• 1 other identifier: XC221-03-03-2020
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 11

Brief Summary

The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2 infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in mild COVID-19 patients during a 14-days treatment. The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200 mg daily dose) in achieving clinical improvement of mild COVID-19 symptoms. The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg daily dose) in mild COVID-19 patients.

Conditions

Sars-CoV-2 Infection

Keywords

COVID-19; Coronavirus

Outcome Measures

Primary Outcomes (2)

• Total incidence frequency of progression to moderate COVID-19 illness or worse throughout the study (by Day 31)

  Moderate illness parameters: * Body temperature \> 37.5°C; * RR \> 22 / min; * Dyspnea during exercise; * Changes in CT (X-Ray) typical of viral disease (the volume of affected area is minimal or medium, CT 1-2); * SpO2 ˂ 95%; * Serum CRP \> 10 mg/l For the symptoms (body temperature, RR, dyspnea during exercise, SpO2, progression to moderate COVID-19 or worse), the presence of moderate progression criteria as shown by the second of two consecutive measurements.

  Day 1 - Day 31

• The median time to a stable decrease in the total score on the COVID-19 Major Symptom Rating Scale to ≤ 1. A stable total score decrease is the presence of 1 point or less as shown by the second of two consecutive measurements

  The COVID-19 Major Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 9 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 27 points) is a sum of points for each symptom.

  Day 1 - Day 31

Secondary Outcomes (29)

• Patient rate with improvement for one or more grades of the WHO Scale by Day 2-31

  Day 1 - Day 31

• Patient rate with worsening for one or more grades of the WHO Scale by Day 2-31

  Day 1 - Day 31

• Mean WHO Scale grade changes from baseline by Day 2-31

  Day 1 - Day 31

• Patient rate with SpO2 ≤ 93% by Day 2-31

  Day 1 - Day 31

• Patient rate with SpO2 ˂ 95% by Day 2-31

  Day 1 - Day 31

Study Arms (2)

XC221

EXPERIMENTAL

XC221 100 mg orally. 1 tablet of XC221 100 mg 2 times a day during 14 full days of treatment period

Drug: XC221

Placebo

PLACEBO COMPARATOR

Placebo orally. 1 tablet of Placebo 2 times a day during 14 full days of treatment period

Drug: Placebo

Interventions

XC221 DRUG

Participants will receive XC221 100 mg 2 times a day during 14 full days

XC221

Placebo DRUG

Participants will receive Placebo 2 times a day during 14 full days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form.
• Patients of both sexes aged 18 to 75 years inclusive.
• Diagnosed COVID-19 based on positive laboratory tests confirming the SARS-CoV-2 presence, performed no earlier than 3 days before screening. It is allowed to determine the SARS-CoV-2 by the PCR or by another method according to the MoH Temporary Guidelines.
• Patients having a total score ≥ 5 according to the COVID-19 Major Symptom Rating Scale.
• Patients with mild COVID-19, as defined in The MoH Temporary Guidelines. Presence of at least two criteria: SpO2 ≥ 95% (required criterion), 37.5°С ≤ t ˂ 38°С, or respiratory rate (RR) ≤ 22 / min. Absence of moderate/severe progression criteria.
• Disease duration is no more than 3 full days since the onset of one or more of symptoms below before the first dose of the drug administration:
• body temperature increase;
• dry cough or cough with little phlegm;
• dyspnoea;
• myalgia;
• fatigue;
• feeling of congestion in the chest;
• reduced sense of smell and / or taste.
• For women only: negative pregnancy test result. Pregnancy testing is not required for women of not childbearing potential (WONCBP): women who are in menopause (defined as an absence of menstruation for at least 2 years or more), or women who undergone surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation), or women with a clinical diagnosis of "infertility". The presence of surgical sterilization and infertility should be confirmed by patient's claim or by relevant document confirming this condition.
• Consent to use reliable method of contraception throughout the study period.

You may not qualify if:

• Known or suspected hypersensitivity to the active substance or to excipients of the drug XC221 or placebo
• Known or suspected hypersensitivity to standard therapy drugs specified in The MoH Temporary Guidelines.
• Body temperature ˂37.5°С.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
• Presence or suspicion of oncological diseases by the day of criteria assessment or in medical history (within the last 2 years).
• Presence of autoimmune diseases by the day of criteria assessment or in medical history.
• Pregnancy.
• Lactation period.
• Presence of serious lung diseases, including, but not limited to the following diseases: moderate and severe bronchial asthma, severe and extremely severe COPD, interstitial lung disease, pulmonary hypertension, pulmonary fibrosis, surgical interventions on the lungs, tuberculosis (including suspicion of tuberculosis based on the results of CT examination at screening).
• Patients with type 1 diabetes mellitus and / or decompensated type 2 diabetes mellitus.
• Heart failure, NYHA functional class III - IV.
• Chronic liver failure stage II (decompensated) and higher.
• The need of replacement renal therapy at enrollment.
• Organ transplantation in medical history.
• Medical history of epilepsy or the need for anticonvulsant therapy.

Sponsors & Collaborators

• RSV Therapeutics LLC: lead

Study Sites (11)

Municipal Budgetary Institution of Healthcare "Central City Hospital of Novoshakhtinsk"

Novoshakhtinsk, Rostov Oblast, 346918, Russia

Location

Regional Budgetary Institution of Healthcare "Ivanovskaya Clinical Hospital named after Kuvaevykh"

Ivanovo, 153025, Russia

Location

State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"

Moscow, 117556, Russia

Location

Federal Budgetary Institution of Science "Moscow Research Institute of Epidemiology and Microbiology named after G.N. Gabrichevsky" of the Federal Service for the Oversight of Consumer Protection and Welfare

Moscow, 125212, Russia

Location

Limited Liability Company "Medical Center "Capital-Policy"

Saint Petersburg, 190013, Russia

Location

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

Location

LLC "Sphere-Med"

Saint Petersburg, 197342, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital" (4th Cardiology Department)

Saint Petersburg, 199106, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "City Polyclinic No. 4"

Saint Petersburg, 199178, Russia

Location

Regional State Budgetary Institution of Healthcare "Medical-Sanitary Unit No. 2"

Tomsk, 634040, Russia

Location

LLC "Family Clinic"

Yekaterinburg, 620000, Russia

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

XC221

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Tablets identical in terms of composition, appearance and labeling to XC221 tablets, but without active substance will be used as Placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two groups (Group A and Group B) in a 1:1 ratio: Group A - investigational product; Group В - Placebo.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 25, 2021
• Study Start: June 26, 2021
• Primary Completion: August 26, 2022
• Study Completion: November 14, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11)