COVID-19NCT04463420
Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19
A study testing PHR160 Spray and Standard treatment in people with COVID-19, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- PHR160 Spray and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteIran
- Study dates
- 15 Aug 2020to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious consent to participate in the study
- Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.
- Strong clinical suspicion of covid 19 with positive findings in CT Scan
- Shortness of breath
Who cannot join
- Patients with HIV
- Patients with cancer undergoing chemotherapy
- Patients receiving Immune Mediators
- Patients need hospitalization in the intensive care unit
- Patients with uncontrolled heart, kidney or liver failure
- Pregnant or lactating women
- Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mohammad Sadegh Bagheri Baghdasht
Tehran, 0
Mohammad Sadegh Bagheri Baghdasht, +989356318204, sadegh.bagheri@gmail.com
About this study
Official title: Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study
This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment
- Conditions
- COVID-19
- Being tested
- PHR160 Spray, Placebo, Standard treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHR160 SprayDrug
One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
PlaceboDrug
participants will receive a placebo spray every hour. This process will continue for 10 days.
: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Receives: Drug: PHR160 Spray; Drug: Standard treatment |
| Control Group | Placebo comparator | Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days Receives: Drug: Placebo; Drug: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.
Measured: up to 14 days
Secondary outcomes (7)
long of hospitalization
The length of time the patient is hospitalized after the diagnosis of COVID-19
Measured: up to 28 days
Radiological Treatment Response
CT scans help determine how much the lungs are affected by COVID-19.
Measured: up to 14 days
Mortality
In-hospital mortality
Measured: Up to 28 days
Allergic drug
There will be known allergic reactions to the drugs.
Measured: up to 14 days
Laboratory Treatment Response
Normal blood cell count and CRP count (normal laboratory range)
Measured: up to 14 days
O2 saturation without supplemental oxygen
Using an oximeter pulse, the amount of oxygen saturation is measured. If the patient is receiving oxygen, first cut off the oxygen for 5 minutes and then measure. If the oxygen drops below 90 degrees, oxygen therapy will be re-established immediately.
Measured: up to 14 days
drug reactions Adverse
Complications in both groups should be evaluated and evaluated during treatment.
protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start15 Aug 2020
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463420
- Sponsor's protocol ID
- IR.BMSU.REC.1399.176
- Status last verified
- Nov 2020
- First submitted
- 4 Jul 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study
- ClinicalTrials.gov ID
- NCT04463420
- Acronym / sponsor ID
- IR.BMSU.REC.1399.176
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center randomized, controlled, and blinded clinical trial study that will be performed in four medical-educational centers. In this study, the samples will be selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and will be randomly divided into two groups, including a control group and an intervention group. The study will be conducted in four medical centers. From each center, 56 definitive Corona patients will be selected, who will be randomly divided into two groups of 28, for a total of 224 patients will enter the study. In the intervention group, in addition to receiving the test spray, Patients will also receive standard treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: PHR160 Spray, Drug: Standard treatmentIntervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. |
| Control Group | Placebo comparator | Drug: Placebo, Drug: Standard treatmentControl group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Conscious consent to participate in the study
- Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.
- Strong clinical suspicion of covid 19 with positive findings in CT Scan
- Shortness of breath
Key exclusion criteria (7 listed)
- Patients with HIV
- Patients with cancer undergoing chemotherapy
- Patients receiving Immune Mediators
- Patients need hospitalization in the intensive care unit
- Patients with uncontrolled heart, kidney or liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHR160 SprayOne puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days. | Drug | Test Group |
| Placeboparticipants will receive a placebo spray every hour. This process will continue for 10 days. | Drug | Control Group |
| Standard treatment: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days | Drug | Control Group, Test Group |
Primary outcome
Dyspnea
Time frame: up to 14 days
shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.
7 secondary outcomes
long of hospitalization
Time frame: up to 28 days
Radiological Treatment Response
Time frame: up to 14 days
Mortality
Time frame: Up to 28 days
Allergic drug
Time frame: up to 14 days
Laboratory Treatment Response
Time frame: up to 14 days
O2 saturation without supplemental oxygen
Time frame: up to 14 days
drug reactions Adverse
Time frame: Up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHR160 Spray and Standard treatment in people with COVID-19, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Sadegh Bagheri Baghdasht (0098 9356318204, sadegh.bagheri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.