Trial IRCT20170207032444N3
Publication Amra B, Research Square, 2021 (preprint)
Dates: 2020-04-01 to 2020-08-30
Funding: Public/non profit (Deputy minister of technology research)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Iran Follow-up duration (days): 28 | |
| Inclusion criteria | Clinical symptoms and signs were compatible with Covid-19 infection ; positive PCR test or lung HRCT abnormalities compatible with Covid-19 pneumonia ; 18-75-year-old men and 50-75-year-old women ; admitted in hospital ; SpO2 less than 85% at admission ; no need to intubation in first 24 hours of admission and no multiorgan failure or shock state at presentation. |
| Exclusion criteria | Hepatic failure (Child Pugh score ≥ C, AST > 5 times of the upper limit normal) or severe renal dysfunction (glomerular filtration rate less than 30 CC per min). |
| Interventions | |
| Treatment
Thalidomide 100 mg orally once a day for 14 days. |
|
| Control
Standard care ( / ) Definition of Standard care: All patients received the usual care for Covid-19 pneumonia based on our hospital protocols. Patients in both groups received methylprednisolone 50 mg intravenously every 12 hours for 3 days and then daily for 7 days, hydroxychloroquine 200 mg orally every 12 hours for 5 days. For symptom control (pain, cough, nausea, and vomiting) acetaminophen codeine, diphenhydramine, dimenhydrinate, and promethazine were prescribed. Antibiotics were administered based on physician choice (Ceftriaxone, Azithromycin, and Vancomycin). All patients received enoxaparin 40 mg subcutaneously daily during hospitalization. | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : 62.6 28 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=51 Critical: n=0 | |
| Primary outcome | |
| In the register Efficacy of Thalidomide in severe Covid19 pneumonia (history, pulse oximetry, sphygmomanometer) Daily until discharge and then weekly until 28 days. | |
| In the report ICU admission rate | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated No |
| 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 assessment of the risk of bias. Neither study protocol nor statistical analysis plan was available. The study achieved its target sample size. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the report (ICU admission rate) was different from that in the registry (efficacy of Thalidomide in severe Covid19 pneumonia by history, pulse oximetry, sphygmomanometer). ICU admission was not included in the registry while the primary outcome in the registry was not reported. The risk of bias was assessed as high due to a much higher proportion of withdrawals and losses to follow up in the standard care arm than in the intervention arm in an unblinded study. |