Trial IRCT20200504047298N3
Publication Siami Z, Int J Infect Dis, 2021 (published paper)
Dates: 2020-08-22 to 2020-10-22
Funding: Public/non profit (Alborz University of Medical
Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Iran Follow-up duration (days): 30 | |
| Inclusion criteria | Adults aged between 18 and 70 years and diagnosed with COVID-19 by positive RT-PCR test or with suspected history; symptoms (cough and dyspnea) and High-resolution computed tomography (HRCT) scan findings accompanied by active clinical disease. |
| Exclusion criteria | Patients with a history of coexisting respiratory diseases (Asthma, Chronic obstructive pulmonary disease, Interstitial lung diseases, etc.) |
| Interventions | |
| Treatment
Ammonium chloride Diphenhydramine compound (12.5 mg Diphenhydramine + 125 mg Ammonium Chloride / 5ml syrup) 10 ml orally 3 times a day for 7 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 120 participants (n1=60 / n2= 60) | |
| Characteristics of participants N=120 Mean age : 52 * males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Change of involvement of lung in HRCT (High-resolution computed tomography) Day 0 and 7 Days later measured by HRCT (High-resolution computed tomography) Change of viral load in Real Time PCR, Day 0 and 7 days later measured by Real Time PCR nasopharyngeal soap | |
| In the report All-cause mortality within 30 days of randomization | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
High |
| General comment |
In addition to the published article, the protocol, statistical plan and retrospective registry (dated September 9th, 2020) were used in data extraction and risk of bias assessment. The study achieved the target sample size of 120 participants specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does not reflect the reported primary outcome. Adverse events are not reported. Some outcomes (e.g. mortality, time to death, time to clinical improvement) are reported in the paper, but were not specified in the trial registry. Baseline severity of patients by proportion per arm were not reported.
On June 07th 2021, we received additional information from authors on this study. This study was updated with data from contact with authors on June 14th, 2021. |