CovidResearchTrials by Shray Alag

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XC221Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug1304 Hydroxychloroquine Sulfate + Azythromycin Wiki 1.00
drug1301 Hydroxychloroquine Sulfate Wiki 0.28
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Multicenter, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XC221, Tablets, 100 mg in Patients With 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 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.

NCT04487574 SARS-CoV-2 Infection Drug: XC221 Drug: Placebo

Primary Outcomes

Description: 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).

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

Time: Day 1 - Day 14

Secondary Outcomes

Description: Body temperature ≤ 37.5°C without using NSAIDs and / or paracetamol; RR ≤ 22 / min without oxygen therapy; SpO2 ≥ 95% without oxygen therapy.

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

Time: Day 1 - Day 28

Description: Body temperature ≤ 37.5°C without using NSAIDs and / or paracetamol; RR ≤ 22 / min without oxygen therapy; SpO2 ≥ 95% without oxygen therapy.

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

Time: Day 1 - Day 28

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

Time: Day 1 - Day 28

Measure: Duration of hospitalization.

Time: Day 1 - Day 28

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

Time: Day 1 - Day 28

Measure: Duration of ICU stay.

Time: Day 1 - Day 28

Measure: Patient rate with ARDS during hospitalization.

Time: Day 1 - Day 28

Measure: Presence of a fatal outcome.

Time: Day 1 - Day 28

Measure: Patient rate requiring oxygen therapy by Day 2-28.

Time: Day 1 - Day 28

Measure: Patient rate requiring high-flow oxygen therapy by Day 2-28.

Time: Day 1 - Day 28

Measure: Patient rate requiring non-invasive ventilation by Day 2-28.

Time: Day 1 - Day 28

Measure: Patient rate requiring invasive ventilation by Day 2-28.

Time: Day 1 - Day 28

Measure: Patient rate requiring extracorporeal membrane oxygenation (EMO) by Day 2-28.

Time: Day 1 - Day 28

Measure: The total duration of oxygen therapy by the last day of hospitalization.

Time: Day 1 - Day 28

Measure: The total duration of high-flow oxygen therapy by the last day of hospitalization.

Time: Day 1 - Day 28

Measure: The total duration of non-invasive ventilation by the last day of hospitalization.

Time: Day 1 - Day 28

Measure: The total duration of invasive ventilation of lungs by the last day of hospitalization.

Time: Day 1 - Day 28

Measure: The total duration of EMO by the last day of hospitalization.

Time: Day 1 - Day 28

Measure: Patient rate with Sp02 > 95% by Day 2-28.

Time: Day 1 - Day 28

Measure: Average alteration of Sp02 by Day 2-28 from baseline.

Time: Day 1 - Day 28

Measure: Average time to reach SpO2 ≥ 95%.

Time: Day 1 - Day 28

Measure: Patient rate with RR < 22 / min by Day 2-28.

Time: Day 1 - Day 28

Measure: Average alteration in RR by Day 2-28 from baseline.

Time: Day 1 - Day 28

Measure: Average time to reach RR ≤ 22 / min.

Time: Day 1 - Day 28

Measure: Patient rate with body temperature < 37.5°C by Day 2-28.

Time: Day 1 - Day 28

Measure: Average alteration in body temperature by Day 2-28 from baseline.

Time: Day 1 - Day 28

Measure: Average time until the patient reaches a body temperature of ≤37.5°C.

Time: Day 1 - Day 28

Measure: Patient rate with CT-1 according to CT data by Day 2-28.

Time: Day 1 - Day 28

Measure: Average alteration in CT data by 1 point in terms of severity (CT-1, CT-2, CT-3, CT-4) by Day 7, 10, 15, 18, 21 and 28 compared to the baseline value.

Time: Day 1 - Day 28

Measure: Average time to reach CT-1 according to CT data.

Time: Day 1 - Day 28

Description: 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) - 6 points (severe cough that makes daytime activity impossible).

Measure: Patient rate with a score < 2 according to the Daytime and Nighttime Cough Scale by Day 2-28.

Time: Day 1 - Day 28

Description: 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) - 6 points (severe cough that makes daytime activity impossible).

Measure: Mean change in Daytime and Nighttime Cough scores by Day 2-28 from baseline.

Time: Day 1 - Day 28

Description: 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) - 6 points (severe cough that makes daytime activity impossible).

Measure: Average time to reach < 2 points when assessed according to the Daytime and Nighttime Cough Scale.

Time: Day 1 - Day 28

Description: The Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 6 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 18 points) is a sum of points for each symptom.

Measure: Patient rate with a score < 1 for each symptom (general fatigue, chest congestion, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale by Day 2-28.

Time: Day 1 - Day 28

Description: The Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 6 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 18 points) is a sum of points for each symptom.

Measure: Average change in score for each symptom (general fatigue, chest congestion, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale by Day 2-28 from baseline.

Time: Day 1 - Day 28

Description: The Symptom Rating Scale will be used to assess the individuals' subjective ratings the severity of 6 symptoms of COVID-19. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 18 points) is a sum of points for each symptom.

Measure: Average time to reach a score of < 1 for each symptom (general fatigue, feeling of congestion in the chest, sore throat, decreased sense of smell and taste, nasal congestion) according to a 4-point scale.

Time: Day 1 - Day 28

Description: 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).

Measure: Patient rate with a transition decrease to category 3 or lower according to the WHO scale by Day 2-13 and Day 15-28.

Time: Day 1 - Day 28

Description: 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).

Measure: Mean WHO grade change by Day 2-28 from baseline.

Time: Day 1 - Day 28

Description: 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).

Measure: Average time to reach the 3rd category or below according to the WHO scale.

Time: Day 1 - Day 28

Description: Parameters will be assessed according to the National Early Warning Score only during hospitalization. During the treatment period, the assessment will be performed 2 times a day. During the follow-up period, the assessment will be performed once a day. The worst result for each period is to be chosen.

Measure: Patient rate with a NEWS score < 2 by Day 2-28.

Time: Day 1 - Day 28

Description: Parameters will be assessed according to the National Early Warning Score only during hospitalization. During the treatment period, the assessment will be performed 2 times a day. During the follow-up period, the assessment will be performed once a day. The worst result for each period is to be chosen.

Measure: Average change in NEWS score by Day 2-28 from baseline.

Time: Day 1 - Day 28

Description: Parameters will be assessed according to the National Early Warning Score only during hospitalization. During the treatment period, the assessment will be performed 2 times a day. During the follow-up period, the assessment will be performed once a day. The worst result for each period is to be chosen.

Measure: Average time to reach a NEWS score ≤ 2.

Time: Day 1 - Day 28

Other Outcomes

Description: (Search Outcome)

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

Time: Day 1 - Day 15

No related HPO nodes (Using clinical trials)