Trial · NCT04682444
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Number of Participants -- Absence of Objective Symptoms -- Overall | Day 0 (baseline), 3, 7, 14. | Count of participants WITHOUT objective symptoms -- overall. Objective symptoms of acute respiratory viral infection (ARVI), including influenza, were monitored: fever, pharyngeal hyperemia, rhinitis, arterial blood pressure, enlarged lymph nodes, auscultation findings for lung and heart. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. A score system used to assess participants' health. A higher score implies worse outcome. Objective symptoms scores were: normal or abnormal blood pressure: 0 or 4 score points; lung auscultation: 0 points; vesicular breath sound and wheezing or crepitation 2 or 4 points, respectively; clear and rhythmic heart sounds -- each 0 points; noisy and arrhythmic heart sounds -- each 2 score points. |
| Primary | Efficacy: Number of Participants -- Days Without Routine Activities -- Summary | Day 0 (baseline), 3, 7, 14. | Count of participants who had days WITHOUT routine activities. Disability to perform routine tasks and activities were reported by the participants to the investigator at each study visit. |
| Primary | Efficacy: Number of Participants -- Viral Antigens -- Overall | Day 0 (baseline), 3, 7. | Viral antigens that were evaluated: adenovirus, corona virus, influenza A, influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was based on the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. Results represent the count of participants who did NOT have detectable viral antigens. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptoms -- Overall | Day 0 (baseline), 3, 7, 14. | Count of participants WITHOUT overall subjective symptoms. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. Evaluate the number of participants in the treatment and the placebo groups without the subjective symptoms from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of ARVI, including influenza. The subjective symptoms were assessed using a 4-point Likert scale, ranging from score 1 (absent symptoms ) to score 4 (severe symptoms). |
| Secondary | Efficacy: Subjective Symptom Sum Score (4-point Likert Scale) | Day 0 (baseline), 3, 7, 14. | Subjective symptom sum score. Subjective symptoms of acute respiratory viral infection (ARVI) including influenza, that were monitored: elevated body temperature, chills, cough, headache, myalgia, sore throat, weakness. The subjective symptoms were assessed using a 4-point Likert scale for the individual assessment of the severity of the above 7 symptoms, ranging from absent (0), mild (1), moderate (2), or severe (3). A higher score implies worse outcome. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Chills | Day 0 (baseline), 3, 7, 14. | Chills. Count of participants WITHOUT the subjective symptom: chills. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Cough | Day 0 (baseline), 3, 7, 14. | Cough. Count of participants WITHOUT the subjective symptom: cough. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Elevated Body Temperature | Day 0 (baseline), 3, 7, 14. | Count of participants WITHOUT perceived elevated body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Sore Throat | Day 0 (baseline), 3, 7, 14. | Subjective symptoms. Count of participants WITHOUT the subjective symptom: sore throat. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Headache | Day 0 (baseline), 3, 7, 14. | Subjective symptoms. Count of participants WITHOUT the subjective symptom: headache. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Myalgia | Day 0 (baseline), 3, 7, 14. | Myalgia. Count of participants WITHOUT the subjective symptom: myalgia. Evaluate the number of participants in the active treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Subjective Symptom -- Weakness | Day 0 (baseline), 3, 7, 14. | Subjective symptoms. Count of participants WITHOUT the subjective symptom: weakness. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, relating to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Objective Symptom -- Body Temperature | Day 0 (baseline), 3, 7, 14. | Efficacy: Count of participants WITHOUT objective symptom: Body temperature. Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1. |
| Secondary | Efficacy: Number of Participants -- Objective Symptom: Body Temperature -- Body Temperature Ranges | Day 0 (baseline), 3, 7, 14. | Body temperature. Count of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Clinical improvement was assessed by the investigator, with respect to the severity of clinical symptoms of acute respiratory viral infection (ARVI), including influenza. |
| Secondary | Efficacy: Number of Participants -- Absence of Objective Symptom -- Lungs Auscultation | Day 0 (baseline), 3, 7, 14. | Efficacy: Count of participants WITHOUT objective symptom: Lungs auscultation (abnormal breath sounds, detected using a stethoscope). Evaluate the number of patients in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1. |
| Secondary | Efficacy: Number of Participants -- Absence of Objective Symptom -- Pharyngeal Hyperemia | Day 0 (baseline), 3, 7, 14. | Efficacy: Number of participants WITHOUT objective Symptom: Pharyngeal Hyperemia. Evaluate the number of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. A score system was used to assess patient health, as described under endpoint #1. |
| Secondary | Efficacy Objective Symptom: Number of Participants -- Pharyngeal Hyperemia -- Severity | Day 0 (baseline), 3, 7, 14. | Pharyngeal hyperemia. Count of participants in the treatment and the placebo groups regarding clinical status from Day 3 after therapy start. Severity was assessed by the investigator, using a 4-point score scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. |
| Secondary | Efficacy: Objective Clinical Sum Score | Day 0 (baseline), 3, 7, 14. | Objective clinical sum score. Objective symptoms of acute respiratory viral infection (ARVI), were monitored. For the objective clinical sum score, clinical status was assessed by the investigator, relating to the severity of clinical symptoms of ARVI, including influenza. A score system (score points) that was used to assess participants' health, was based on objective symptoms scores, shown below. * Blood pressure: normal=0 points; abnormal=4 points. * Lung auscultation: vesicular breath sound=0 points; wheezing=2 points; crepitation=4 points. * Heart sound; clear heart sounds=0 points; rhythmic heart sounds=0 points; noisy heart sounds=2 points; arrhythmic heart sounds=2 points. A higher score implies worse clinical outcome. |
| Secondary | Efficacy: Number of Participants -- Viral Antigens -- Baseline Status | Day 0 (baseline). | Count of randomised participants and their viral antigen types at baseline. Viral antigens evaluated: adenovirus, corona virus, influenza A (and subtypes), influenza B, parainfluenza virus, respiratory syncytial virus. Virus antigens were isolated from nasal swabs and detected by using validated immunofluorescence staining methods. |
| Secondary | Efficacy: Number of Participants -- Viral Antigen -- Influenza Type A | Day 0 (baseline), 3, 7. | Count of participants who did NOT have a detectable viral antigen -- influenza Type A Virus antigen was isolated from nasal swabs and detected by using validated immunofluorescence staining methods. Efficacy assessment was the determination of viral antigen on treatment days (Day 3 and Day 7) compared with the baseline (Day 0) in the active treatment group and the placebo group. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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