Evaluation of efficacy and safety of Qiangzhu-qinggan formula as an adjunctive therapy in adult patients with severe influenza

Phase 1

• Conditions: influenza

• Registration Number: ITMCTR2000002885
• Lead Sponsor: onghua Hospital Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of influenza A and/or B by a positive Rapid Influenza Diagnostic Test (RIDT) or reverse transcriptase-polymerase chain reaction (RT-PCR). Positive results from local tests are acceptable if conducted within the 24 hours prior to screening. A patient with a negative RIDT may be enrolled if influenza is suspected based on local surveillance data or if the patient reports contact with a known case of influenza within the prior 7 days and all other inclusion criteria are met.
2. Granting of written informed consent.
3. Male or female aged 18 to 65 years at the time of signing Informed Consent Form.
4. Ability to comply with the study protocol, in the investigators judgment.
5. Participants who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization.
6. Participants will require at least one of the following objective criteria of severe influenza:
(1) duration with axillary temperature over 39 degrees Celsius >= 3 days, accompanied by severe cough, sputum, blood sputum, or chest pain;
(2) rapid respiratory rate(>= 30 times per minute), difficulty breathing and cyanosis of lips;
(3) arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) <= 94% in room air condition;
(4) Requires ventilation or supplemental oxygen to support respiration;
(5) with only one complication related to influenza (e.g., pneumonia, central nervous system involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, asthma or chronic obstructive pulmonary disease (COPD), severe dehydration, myocarditis, pericarditis, exacerbation of ischemic heart disease).
7. The time interval between the onset of symptoms and randomization is within 96 hours. The onset of symptoms is defined as either: Time of the first increase in body temperature (>=38?); Time when the patient experiences at least one general or respiratory symptom.
8. Conforming to the standard of TCM syndrome differentiation.

Exclusion Criteria

1. Aged <18 years or >65 years.
2. Participants hospitalized for exclusively social reasons (e.g., lack of caregivers at home).
3. Participants expected to be discharged within 48 hours, according to the investigator's judgement.
4. Participants weighing < 40 kg.
5. Participants who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening.
6. Participants with known severe renal impairment or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
7. Participants with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges:
(1)Alanine Transaminase (ALT) or Aspartate Transaminase (AST) level > 5 times the upper limit of normal (ULN).
(2)ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN.
8. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
9. With mental changes or convulsions (e.g., slow response, drowsiness and restlessness).
10. With severe gastrointestinal symptoms (e.g., severe nausea, vomiting, diarrhea and even dehydration).
11. With one of the following critical illnesses: respiratory failure, acute necrotic encephalopathy, septic shock, multiple organ dysfunction, or other serious clinical conditions requiring intensive care.
12. With tuberculosis, measles, AIDS or other infectious diseases.
13. Women who are pregnant (including a positive pregnancy test at enrollment), breastfeeding, or within 2 weeks post-partum.
14. Known history of allergy or severe intolerance of oseltamivir and herbal medicines, as determined by the investigator.
15. Currently or have been involved in another anti-influenza treatment trial in the last 28 days.
16. Patients who have been treated with oral Chinese medicine within 4 weeks.
17. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of clinical improvement within 7 days;

Secondary Outcome Measures

Name	Time	Method
Percentage of participants whose symptoms were improved at each time point;Time to clinical improvement of symptoms;Body temperature at each time point;Percentage of participants requiring systemic antibiotics for infections secondary to influenza;Percentage of participants with 2 or more Influenza-related complications;Inpatient length of stay defined as number of days in hospital;Median Time (Days) Receipt of Oxygen;Percentage of participants with adverse events (AEs);Percentage of participants reporting normal temperature at each time point;Time to defervescence (TTD);