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Effect of new trial drug on clinical and paraclinical symptoms in COVID-19

Effect of new trial drug on improving of clinical and paraclinical symptoms in patients ICU with COVID-19

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200509047373N2
Enrollment
120
Registered
2021-04-13
Start date
2021-04-14
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19, virus identified

Interventions

Intervention 1: In the intervention group, participants will receive new trial drug 6 drops every 3hours for 14 days. The control group will receive a placebo (no therapeutic value), resembled the

Sponsors

Health Medicine Chemistry Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: Having definite COVID-19 disease and get hospitalized Both sexes Age over 15 years Obtaining informed consent to participate in the trial Non-participation in another clinical trial simultaneously Patients admitted to ICU

Exclusion criteria

Exclusion criteria: Diagnosis of the disease just based on physician diagnosis Pregnancy (according to the patient's statement and examination by a physician) Breastfeeding (according to the patient's statement)

Design outcomes

Primary

MeasureTime frame
Respiratory Rate. Timepoint: Daily. Method of measurement: Observation.;Oxygen saturation (SpO2). Timepoint: Daily. Method of measurement: Pulse Oximeter.;Serum White Blood Cell count. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Laboratory cell counter.;Serum CRP level. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Biochemical method.;ESR (Erythrocyte Sedimentation Rate). Timepoint: Before intervention and 14 days after intervention. Method of measurement: Checking the sedimentation rate of erythrocytes in a special tube within one hour.;Number of hospitalization days. Timepoint: After intervention. Method of measurement: Questionnaire.;Mortality. Timepoint: Daily. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
The end time of dry Cough. Timepoint: Daily. Method of measurement: ?Daily symptom recording questionnaire.;The time of recovery from difficulty in breathing or shortness of breath. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.;The time of recovery of temperature equal to or grater than 37.8 C. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Hosseinpour

Health Medicine Chemistry Company

ahosseinpour3@gmail.com+98 71 3739 7910

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026