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Evaluation of the effectiveness of PHR-160 spray in hospitalized patients with Covid-19

Evaluation of the effectiveness of PHR-160 spray in hospitalized COVID-19 patients with severe lung involvement in improving oxygen saturation; a randomized clinical trial study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201223049816N1
Enrollment
240
Registered
2021-01-11
Start date
2020-12-20
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

covid-19. COVID-19

Interventions

Intervention 1: Intervention group: 1. Phr-160 spray group: PHR spray:160 micrograms per puff, 1 puff every 1 hour up to ten times a day, on days 1 to 10 (use of Damir is required) in addition to the

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: Both sexes Ages 15-75 Oxygen saturation percentage between 88 and 93%. Confirmation of 19 patients using RTPCR. Confirmation of Covid-19 using CT scan Signing a informed consent form

Exclusion criteria

Exclusion criteria: Attending another trial in the last three months pregnancy/lactation drug sensitivity to the ingredients in the intervention very high severity of the disease in the emergency room (consciousness less than 15 / oxygen concentration less than 88%, etc) history of chronic respiratory disease Previous pulmonary embolism (last three months)

Design outcomes

Primary

MeasureTime frame
Percentage of oxygen saturation in two intervention groups after randomization. Timepoint: 1. After randomization at the beginning of the patient's arrival, and every day. Method of measurement: Using Pulse Oximeter.

Secondary

MeasureTime frame
The time required to reduce at least one grade of disease severity according to the Covid-19 national guideline. Timepoint: Every day. Method of measurement: Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.;Number and percentage of patients with adverse events and number and percentage of total adverse events. Timepoint: Evry day. Method of measurement: Data collection and data management will be done using electronic patient report forms and electronic data management system, and the steps of data cleaning and locking and data monitoring will be done on-line during the study.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Hassan Saadat

Bagheiat-allah University of Medical Sciences

saadat350@gmail.com+98 21 8860 0067

Outcome results

None listed

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