The Effect of Early Hydroxychloroquine-based Therapy in COVID-19 Patients in Ambulatory Care Settings: A Nationwide Prospective Cohort Study
Sulaiman et al.
, The Effect of Early Hydroxychloroquine-based Therapy in COVID-19 Patients in Ambulatory Care Settings: A..
, medRxiv, doi:10.1101/2020.09.09.20184143 (Preprint)
Observational prospective 5,541 patients, adjusted HCQ mortality odds ratio OR 0.36, p = 0.012. Adjusted hospitalization OR 0.57, p < 0.001. Zinc supplementation was used in all cases. Early treatment in ambulatory fever clinics in Saudi Arabia.
risk of death, 63.7% lower, RR 0.36, p = 0.01, treatment 7 of 1,817 (0.4%), control 54 of 3,724 (1.5%), NNT 94, adjusted per study, odds ratio converted to relative risk.
risk of hospitalization, 38.6% lower, RR 0.61, p = 0.001, treatment 171 of 1,817 (9.4%), control 617 of 3,724 (16.6%), NNT 14, adjusted per study, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sulaiman et al., 13 Sep 2020, prospective, Saudi Arabia, preprint, 22 authors, dosage 400mg bid day 1, 200mg bid days 2-5.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.09.09.20184143; this version posted September 13, 2020. The copyright holder for this
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The Effect of Early Hydroxychloroquine-based Therapy in COVID-19
Patients in Ambulatory Care Settings: A Nationwide Prospective Cohort
Authors: Tarek Sulaiman, Abdulrhman Mohana, Laila Alawdah, Nagla Mahmoud, Mustafa Hassanein,
Tariq Wani, Amel Alfaifi, Eissa Alenazi, Nashwa Radwan, Nasser AlKhalifah, Ehab Elkady, Manwer
Alanazi, Mohammed Alqahtani, Khalid Abdullah, Yousif Yousif, Fouad AboGazalah, Fuad Awwad,
Khaled Alabdulkareem, Fahad AlGhofaili, Ahmad AlJedai, Hani Jokhdar, Fahad Alrabiah
BACKGROUND: Currently, there is no proven effective therapy nor vaccine for the treatment
of SARS-CoV-2. Evidence regarding the potential benefit of early administration of
hydroxychloroquine (HCQ) therapy in symptomatic patients with Coronavirus Disease
(COVID-19) is not clear.
METHODS: This observational prospective cohort study took place in 238 ambulatory fever
clinics in Saudi Arabia, which followed the Ministry of Health (MOH) COVID-19 treatment
guideline. This guideline included multiple treatment options for COVID-19 based on the best
available evidence at the time, among which was Hydroxychloroquine (HCQ). Patients with
confirmed COVD-19 (by reverse transcriptase polymerase chain reaction (PCR) test) who
presented to these clinics with mild to moderate symptoms during the period from 5-26 June
2020 were included in this study. Our study looked at those who received HCQ-based therapy
along with supportive care (SC) and compared them to patients who received SC alone. The
primary outcome was hospital admission within 28-days of presentation. The secondary
outcome was a composite of intensive care admission (ICU) and/or mortality during the followup period. Outcome data were assessed through a follow-up telephonic questionnaire at day
28 and were further verified with national hospitalisation and mortality registries. Multiple
logistic regression model was used to control for prespecified confounders.
RESULTS: Of the 7,892 symptomatic PCR-confirmed COVID-19 patients who visited the
ambulatory fever clinics during the study period, 5,541 had verified clinical outcomes at day
28 (1,817 patients in the HCQ group vs 3,724 in the SC group). At baseline, patients who
received HCQ therapy were more likely to be males who did not have hypertension or chronic
lung disease compared to the SC group. No major differences were noted regarding other
comorbid conditions. All patients were presenting with active complaints; however, the HCQ
groups had higher rates of symptoms compared to the SC group (fever: 84% vs 66.3, headache:
49.8 vs 37.4, cough: 44.5 vs 35.6, respectively). Early HCQ-based therapy was associated with
a lower hospital admission within 28-days compared to SC alone (9.4% compared to 16.6%,
RRR 43%, p-value <0.001). The composite outcome of ICU admission and/or mortality at 28days was also lower in the HCQ group compared to the SC (1.2% compared to 2.6%, RRR
54%, p-value 0.001). Adjusting for age, gender, and major comorbid conditions, a multivariate
logistic regression model showed a decrease in the odds of hospitalisation in patients who
received HCQ compared to SC alone (adjusted OR..
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