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

NCT04487574 | Completed Phase 3 DMC

• 1 other identifier: XC221-03-02-2020
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

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 COVID-19 patients during a 14-day 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 COVID-19 symptoms. The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg daily dose) in COVID-19 patients.

Conditions

SARS-CoV-2 Infection

Keywords

COVID19; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Patient rate with a transition to category 3 or lower according to the WHO scale by Day 14 after the beginning of drug administration.

  The scale of the patient's clinical condition, proposed by the WHO, will be used to assess the severity of patient general condition. Ranges for patient's clinical condition: 0 points (no infection) - 8 points (death).

  Day 1 - Day 14

Secondary Outcomes (42)

• Time till clinical improvement, which is described by presence of all of the following factors during 48 hours in a row.

  Day 1 - Day 28

• Patient rate with clinical improvement by day 2-28. Presence of all of the following factors during 48 hours in a row.

  Day 1 - Day 28

• Patient rate with a negative test result for SARS-CoV-2 by Day 7±1, 15±1, 21 ±1 and 28 ± 1.

  Day 1 - Day 28

• Duration of hospitalization.

  Day 1 - Day 28

• Patient rate transferred to the intensive care unit (ICU) during hospitalization.

  Day 1 - Day 28

Other Outcomes (1)

• Concentration of IL-6 on Days 3 ± 1, 7 ± 1, 15 ± 1.

  Day 1 - Day 15

Study Arms (2)

XC221

EXPERIMENTAL

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

Drug: XC221

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

XC221 DRUG

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

XC221

Placebo DRUG

Participants will receive Placebo 2 times a day during 14 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 14 days before hospitalization. It is allowed to determine the SARS-CoV-2 by the PCR or by another method according to the MoH Temporary Guidelines; and / or
• bilateral alterations in lungs, typical for COVID-19, according to CT scan of the chest.
• Patients with moderate or severe form of disease (t \> 38.0°C; respiratory rate (RR) \>22 / min; Sp02 \<95%) not requiring non-invasive / invasive ventilation and / or high-flow oxygenation (HFNT), and / or extracorporeal membrane oxygenation (EMO) at the time of screening and randomization (based on the MoH Temporary Guidelines).
• Patients requiring oxygen therapy (oxygenation through a nasal cannula, a simple facemask or other similar oxygen delivery device) with a category "4" according to the WHO scale.

You may not qualify if:

• Disease duration is no more than 7 full days since the moment of appearing one or more of the symptoms below until the first dose of the drug administration:
• temperature increase;
• dry cough or cough with little phlegm;
• shortness of breath;
• 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.
• Patients who are able to understand and comply with treatment and procedures during the study.
• 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.
• 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).

Sponsors & Collaborators

• RSV Therapeutics LLC: lead

Study Sites (5)

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

Novoshakhtinsk, Rostov Oblast, 346918, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "City Hospital No. 40 of Kurortny District"

Saint Petersburg, 197706, 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 Pokrovskaya Hospital"

Saint Petersburg, 199106, Russia

Location

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

Tomsk, 634040, 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

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: July 25, 2020
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)