Trial CTRI/2020/07/026354
Publication Shah M, Int Immunopharmacol, 2021 (published paper)
Funding: Private (Bisleri Charitable Trust, India)
Conflict of interest: *
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / India Follow-up duration (days): 10 | |
| Inclusion criteria | Adults of age 30 to 60 of both sex with COVID-19 positive Reverse transcription polymerase chain reaction (RT-PCR) from nasopharyngeal swab test result presenting mild to moderately severe disease (NEWS score ≤ 8) and willing to provide informed consent. |
| Exclusion criteria | Participants requiring Intensive Care Unit (ICU) admission and or artificial ventilation or any other co-morbidity (which were at critical stage at screening) ; Participants with chronic constipation for more than 7 days at the time of screening or with glucose-6-phosphate-dehydrogenase deficiency (G6PD) deficiency ; Participants from the vulnerable group like pregnant and breastfeeding women. |
| Interventions | |
| Treatment
Oxygen-Ozone 40 mcg/ml at 150 ml twice daily rectally + minor auto haemotherapy (2–3 ml IV + 5 ml at 25 mcg/ml) for 10 days |
|
| Control
Standard care Definition of Standard care: Conventional care as recommended in Clinical management protocol for COVID 19 advocated by Indian Council of Medical Research (ICMR), Ministry of Health and Family Welfare, Government of India | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : 43.8 48 males Severity : Mild: n=60 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Changes in X-ray chest: interstitial pattern. Changes in hematological parameters like- blood cell counts (Absolute and differential) Changes in oxygenation index: SpO2. Changes in serum inflammation parameters like LDH, CRP, ferritin Changes in NEWS (National Early Warning Score) Number of days for negative RT-PCR test for Covid 19 | |
| In the report Changes in oxygenation index: SpO2; Changes in serum Lactate dehydrogenase (LDH), Ferritin and C-reactive protein (CRP); Changes in NEWS (National Early Warning Score); Number of days for negative RT-PCR test for COVID 19. RT- PCR test was repeated on day 5 and 10 | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plane was available. Some primary and secondary outcomes recorded in the trial registry were not reported. Adverse events were not reported as described in the methods section and were not extracted. There is no important change from the trial registration in the intervention and control treatments, and the study achieved its pre-stated target sample size. |