Trial ISRCTN16806663
Publication Moni M, IMD (2022) (published paper)
Dates: 2020-09-20 to 2020-12-12
Funding: Public/non profit (Collaborating centre, the Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham.)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / India Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
iNO administered in a crescendo-decrescendo fashion in doses from 10 ppm 0-5 mins to 80 ppm-0 ppm, 23-30 minutes, inhaled through a mask for 3 days |
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Control
Standard care | |
Participants | |
Randomized participants : iNO=14 Standard care=15 | |
Characteristics of participants N= 29 Mean age : NR 18 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=25 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Viral load as defined by cycle threshold measured using Real-Time Polymerase Chain Reaction Surrogate CT ratio from nasopharyngeal swab collected at baseline 3, 5, 7, 10, and 14 days | |
In the report Decline in viral load, as defined by a surrogate change in the RT-PCR cycle threshold; time to improvement of >2 points on the WHO Ordinal Scale (WOS) | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported |
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 pre-print article, the retrospective trial registry was used in data extraction and risk of bias assessment. Neither the protocol nor statistical analysis plan was available. Inclusion criteria differ slightly between the pre-print article and the retrospective registry. The pre-print article included a co-primary outcome not included in the registry (improvement of > 2 points on a 8 point ordinal scale). The trial achieved it target sample size. The trial was assessed to be at a high risk of bias because of uneven withdrawal of consent in an open-label study (26.7% in the standard care arm versus none in the treatment arm) and because of some concerns in all other domains. This trial was updated on April 13th, 2022 after publication of study report. |