Sars-CoV-2 InfectionPhase 3NCT04940182
A Study to Assess the Efficacy and Safety of XC221 in Patients With Mild COVID-19
A Phase 3 study testing XC221 in people with Sars-CoV-2 Infection, run by RSV Therapeutics LLC at 11 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- XC221
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 11 sitesRussia
- Study dates
- 26 Jun 2021to 14 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Patients who are able to understand and comply with treatment and procedures during the study.
Who cannot join
- 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.
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- 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.
- Major depressive disorder, anxiety, other mental disorders requiring medical correction.
- Acute cerebrovascular accident, stroke or transient ischemic attack within 90 days before screening.
- Use of any antiviral and / or immunomodulatory drugs after the manifestation of COVID-19.
- Any immunosuppressive therapy (including tocilizumab / sarilumab) within 90 days prior to randomization, or the need of immunosuppressive therapy at the time of randomization.
- Use of anti-COVID-19 plasma within 14 days prior to the screening visit.
- Use of systemic glucocorticosteroids within 90 days prior to randomization, or the need of systemic glucocorticosteroids at the time of randomization.
- Use of vaccines against viral infections within 90 days prior to randomization.
- Patients receiving other experimental drugs, drugs not approved in the Russian Federation, or participating in other clinical trials within 30 days before screening.
- Patients abusing alcohol or psychotropic drugs and other drugs by the day of criteria assessment or during the last year.
- Patients with other serious, unstable, or clinically significant medical or psychological conditions that, in the opinion of the investigator, may preclude the patient's participation in the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Regional Budgetary Institution of Healthcare "Ivanovskaya Clinical Hospital named after Kuvaevykh"
Ivanovo, 153025
State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
Moscow, 117556
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
Municipal Budgetary Institution of Healthcare "Central City Hospital of Novoshakhtinsk"
Novoshakhtinsk, Rostov Oblast, 346918
Limited Liability Company "Medical Center "Capital-Policy"
Saint Petersburg, 190013
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, 196143
LLC "Sphere-Med"
Saint Petersburg, 197342
Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital" (4th Cardiology Department)
Saint Petersburg, 199106
Saint Petersburg State Budgetary Institution of Healthcare "City Polyclinic No. 4"
Saint Petersburg, 199178
Regional State Budgetary Institution of Healthcare "Medical-Sanitary Unit No. 2"
Tomsk, 634040
LLC "Family Clinic"
Yekaterinburg, 620000
About this study
Official title: A Multicenter, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XC221, Tablets, 100 mg in Patients With Mild COVID-19
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.
Read the detailed description
8 Russian centers will participate in this study. The trail will consist of three periods: screening (duration not more than 1 day, it may coincide with the randomization visit and beginning of drug administration), treatment period (14 full days) and follow-up period (15 ± 1 days after completion of treatment with XC221 / Placebo). The duration of participation in the study for each patient will be no more than 32 days.
274 eligible patients with confirmed COVID-19 will be randomized into two groups (Group A and Group B) in a 1:1 ratio: Group A - XC221 200 mg daily (137 patients); Group В - Placebo (137 patients).
During the treatment period (14 full days), 1 tablet of XC221 / Placebo will be administered 2 times a day in addition to the standard of care (SoC) for COVID-19 according to The Temporary guidelines for the prevention, diagnosis and treatment of SARS-CoV-2 infection of the Ministry of Health of the Russian Federation (the MoH Temporary Guidelines). The follow-up period will last for 15 ± 1 days.
- Conditions
- Sars-CoV-2 Infection
- Being tested
- XC221, Placebo
- Keywords
- COVID-19, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC221Drug
Participants will receive XC221 100 mg 2 times a day during 14 full days
PlaceboDrug
Participants will receive Placebo 2 times a day during 14 full days
| Study group | Role | What they receive |
|---|---|---|
| XC221 | Experimental | XC221 100 mg orally. 1 tablet of XC221 100 mg 2 times a day during 14 full days of treatment period Receives: Drug: XC221 |
| Placebo | Placebo comparator | Placebo orally. 1 tablet of Placebo 2 times a day during 14 full days of treatment period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 - Day 31
Secondary outcomes (29)
Patient rate with improvement for one or more grades of the WHO Scale by Day 2-31
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).
Measured: Day 1 - Day 31
Patient rate with worsening for one or more grades of the WHO Scale by Day 2-31
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).
Measured: Day 1 - Day 31
Mean WHO Scale grade changes from baseline by Day 2-31
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).
Measured: Day 1 - Day 31
Patient rate with SpO2 ≤ 93% by Day 2-31
Measured: Day 1 - Day 31
Patient rate with SpO2 ˂ 95% by Day 2-31
Measured: Day 1 - Day 31
Mean change from baseline in SpO2 by Day 2-31
Measured: Day 1 - Day 31
Patient rate with RR > 22/min by Days 3, 6, 9, 12 and 15
Measured: Day 1 - Day 15
Patient rate with RR > 30/min by Days 3, 6, 9, 12 and 15
Measured: Day 1 - Day 15
Patient rate with RR ≤ 20/min by Days 3, 6, 9, 12 and 15
Measured: Day 1 - Day 15
Mean change from baseline in RR by Days 3, 6, 9, 12 and 15
Measured: Day 1 - Day 15
Patient rate with a body temperature ≤ 37.0°С by Day 2-31
Measured: Day 1 - Day 31
Patient rate with a body temperature ≤ 37.5°С by Day 2-31
Measured: Day 1 - Day 31
Patient rate with a body temperature ≥ 38.5°С by Day 2-31
Measured: Day 1 - Day 31
Mean change from baseline in body temperature by Day 2-31
Measured: Day 1 - Day 31
Patient rate with a score ≤ 1 according to the Daytime and Nighttime Cough Scale by Day 2-31
Measured: Day 1 - Day 31
Mean score change from baseline in the Daytime and Nighttime Cough Scale by Day 2-31
The Daytime and Nighttime Cough Scale will be used to assess the dynamics of cough during the study. Ranges for assess: 0 points (no cough) - 5 points (cough that prevents sleep).
Measured: Day 1 - Day 31
Average time to reach ≤ 1 score according to the Daytime and Nighttime Cough.
The Daytime and Nighttime Cough Scale will be used to assess the dynamics of cough during the study. Ranges for assess: 0 points (no cough) - 5 points (cough that prevents sleep).
Measured: Day 1 - Day 31
Patient rate with decrease for one or more grades for each symptom according to the COVID-19 Major Symptom Rating Scale by Day 2-31
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.
Measured: Day 1 - Day 31
Patient rate with clinical improvement (1 point or less) for each symptom according to the COVID-19 Major Symptom Rating Scale
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.
Measured: Day 1 - Day 31
Time till clinical improvement (1 point or less) for each symptom according to the COVID-19 Major Symptom Rating Scale
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.
Measured: Day 1 - Day 31
Patient rate with a grade ≤ 1 for each symptom according to the COVID-19 Major Symptom Rating Scale by Day 2-31
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.
Measured: Day 1 - Day 31
Mean score change from baseline for each symptom according to the COVID-19 Major Symptom Rating Scale by Day 2-31
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.
Measured: Day 1 - Day 31
Average time to reach ≤ 1 score for each symptom according to the COVID-19 Major Symptom Rating Scale
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.
Measured: Day 1 - Day 31
Patient rate with a grade ≤ 1 according to the Dyspnea Visual Analogue Scale by Day 2-31
The Dyspnea Visual Analogue Scale will be used to assess the severity of dyspnea. The scale has five numerical values, rated from 0 (no shortness of breath) to 4 (very severe shortness of breath).
Measured: Day 1 - Day 31
Mean score change from baseline according to the Dyspnea Visual Analogue Scale by Day 2-31
The Dyspnea Visual Analogue Scale will be used to assess the severity of dyspnea. The scale has five numerical values, rated from 0 (no shortness of breath) to 4 (very severe shortness of breath).
Measured: Day 1 - Day 31
Average time to reach ≤ 1 score according to the Dyspnea Visual Analogue Scale
The Dyspnea Visual Analogue Scale will be used to assess the severity of dyspnea. The scale has five numerical values, rated from 0 (no shortness of breath) to 4 (very severe shortness of breath).
Measured: Day 1 - Day 31
Patient rate with a negative SARS-CoV-2 test result by Day 3, 9, 15, also by Day 7 and Day 15 after the end of drug administration (in the case of a positive previous test result)
Measured: Day 1 - Day 31
Time till elimination SARS-CoV-2
Measured: Day 1 - Day 31
Mean CRP concentration change from baseline by Day 15
Measured: Day 1 - Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start26 Jun 2021
- Primary completion26 Aug 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups (Group A and Group B) in a 1:1 ratio: Group A - investigational product; Group В - Placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSV Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940182
- Sponsor's protocol ID
- XC221-03-03-2020
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XC221, Tablets, 100 mg in Patients With Mild COVID-19
- ClinicalTrials.gov ID
- NCT04940182
- Acronym / sponsor ID
- XC221-03-03-2020
- Conditions
- Sars-CoV-2 Infection
- Keywords
- COVID-19, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- RSV Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
8 Russian centers will participate in this study. The trail will consist of three periods: screening (duration not more than 1 day, it may coincide with the randomization visit and beginning of drug administration), treatment period (14 full days) and follow-up period (15 ± 1 days after completion of treatment with XC221 / Placebo). The duration of participation in the study for each patient will be no more than 32 days.
274 eligible patients with confirmed COVID-19 will be randomized into two groups (Group A and Group B) in a 1:1 ratio: Group A - XC221 200 mg daily (137 patients); Group В - Placebo (137 patients).
During the treatment period (14 full days), 1 tablet of XC221 / Placebo will be administered 2 times a day in addition to the standard of care (SoC) for COVID-19 according to The Temporary guidelines for the prevention, diagnosis and treatment of SARS-CoV-2 infection of the Ministry of Health of the Russian Federation (the MoH Temporary Guidelines). The follow-up period will last for 15 ± 1 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups (Group A and Group B) in a 1:1 ratio: Group A - investigational product; Group В - Placebo.
| Arm | Type | Receives |
|---|---|---|
| XC221 | Experimental | Drug: XC221XC221 100 mg orally. 1 tablet of XC221 100 mg 2 times a day during 14 full days of treatment period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally. 1 tablet of Placebo 2 times a day during 14 full days of treatment period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC221Participants will receive XC221 100 mg 2 times a day during 14 full days | Drug | XC221 |
| PlaceboParticipants will receive Placebo 2 times a day during 14 full days | Drug | Placebo |
Primary outcome
Total incidence frequency of progression to moderate COVID-19 illness or worse throughout the study (by Day 31)
Time frame: Day 1 - 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.
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
Time frame: Day 1 - Day 31
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.
29 secondary outcomes
Patient rate with improvement for one or more grades of the WHO Scale by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with worsening for one or more grades of the WHO Scale by Day 2-31
Time frame: Day 1 - Day 31
Mean WHO Scale grade changes from baseline by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with SpO2 ≤ 93% by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with SpO2 ˂ 95% by Day 2-31
Time frame: Day 1 - Day 31
Mean change from baseline in SpO2 by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with RR > 22/min by Days 3, 6, 9, 12 and 15
Time frame: Day 1 - Day 15
Patient rate with RR > 30/min by Days 3, 6, 9, 12 and 15
Time frame: Day 1 - Day 15
Patient rate with RR ≤ 20/min by Days 3, 6, 9, 12 and 15
Time frame: Day 1 - Day 15
Mean change from baseline in RR by Days 3, 6, 9, 12 and 15
Time frame: Day 1 - Day 15
Patient rate with a body temperature ≤ 37.0°С by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with a body temperature ≤ 37.5°С by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with a body temperature ≥ 38.5°С by Day 2-31
Time frame: Day 1 - Day 31
Mean change from baseline in body temperature by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with a score ≤ 1 according to the Daytime and Nighttime Cough Scale by Day 2-31
Time frame: Day 1 - Day 31
Mean score change from baseline in the Daytime and Nighttime Cough Scale by Day 2-31
Time frame: Day 1 - Day 31
Average time to reach ≤ 1 score according to the Daytime and Nighttime Cough.
Time frame: Day 1 - Day 31
Patient rate with decrease for one or more grades for each symptom according to the COVID-19 Major Symptom Rating Scale by Day 2-31
Time frame: Day 1 - Day 31
Patient rate with clinical improvement (1 point or less) for each symptom according to the COVID-19 Major Symptom Rating Scale
Time frame: Day 1 - Day 31
Time till clinical improvement (1 point or less) for each symptom according to the COVID-19 Major Symptom Rating Scale
Time frame: Day 1 - Day 31
Patient rate with a grade ≤ 1 for each symptom according to the COVID-19 Major Symptom Rating Scale by Day 2-31
Time frame: Day 1 - Day 31
Mean score change from baseline for each symptom according to the COVID-19 Major Symptom Rating Scale by Day 2-31
Time frame: Day 1 - Day 31
Average time to reach ≤ 1 score for each symptom according to the COVID-19 Major Symptom Rating Scale
Time frame: Day 1 - Day 31
Patient rate with a grade ≤ 1 according to the Dyspnea Visual Analogue Scale by Day 2-31
Time frame: Day 1 - Day 31
Mean score change from baseline according to the Dyspnea Visual Analogue Scale by Day 2-31
Time frame: Day 1 - Day 31
Average time to reach ≤ 1 score according to the Dyspnea Visual Analogue Scale
Time frame: Day 1 - Day 31
Patient rate with a negative SARS-CoV-2 test result by Day 3, 9, 15, also by Day 7 and Day 15 after the end of drug administration (in the case of a positive previous test result)
Time frame: Day 1 - Day 31
Time till elimination SARS-CoV-2
Time frame: Day 1 - Day 31
Mean CRP concentration change from baseline by Day 15
Time frame: Day 1 - Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XC221 in people with Sars-CoV-2 Infection, run by RSV Therapeutics LLC at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total incidence frequency of progression to moderate COVID-19 illness or worse throughout the study (by Day 31) (time frame: Day 1 - Day 31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.