Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Early Hydroxychloroquine Is Associated with an Increase of Survival in COVID-19 Patients: An Observational Study

Version 1 : Received: 2 May 2020 / Approved: 5 May 2020 / Online: 5 May 2020 (03:32:22 CEST)
Version 2 : Received: 6 May 2020 / Approved: 9 May 2020 / Online: 9 May 2020 (04:45:37 CEST)

How to cite: Membrillo de Novales, F.J.; Ramírez-Olivencia, G.; Estébanez, M.; de Dios, B.; Herrero, M.D.; Mata, T.; Borobia, A.M.; Gutiérrez, C.; Simón, M.; Ochoa, A.; Martínez, Y.; Aguirre, A.; Alcántara, F.D.A.; Fernández-González, P.; López, E.; Campos, S.; Navarro, M.; Ballester, L.E. Early Hydroxychloroquine Is Associated with an Increase of Survival in COVID-19 Patients: An Observational Study. Preprints 2020, 2020050057 (doi: 10.20944/preprints202005.0057.v1). Membrillo de Novales, F.J.; Ramírez-Olivencia, G.; Estébanez, M.; de Dios, B.; Herrero, M.D.; Mata, T.; Borobia, A.M.; Gutiérrez, C.; Simón, M.; Ochoa, A.; Martínez, Y.; Aguirre, A.; Alcántara, F.D.A.; Fernández-González, P.; López, E.; Campos, S.; Navarro, M.; Ballester, L.E. Early Hydroxychloroquine Is Associated with an Increase of Survival in COVID-19 Patients: An Observational Study. Preprints 2020, 2020050057 (doi: 10.20944/preprints202005.0057.v1).

Abstract

Background: There is no treatment proven effective against COVID-19. Several drugs with in vitro potential against SARS-CoV-2 virus have been proposed. Hydroxychloroquine has in vitro anti-viral and immunomodulatory activity, but there is no current clinical evidence of its effectiveness changing the outcome of the disease. Methods: We enrolled all 18-85 years old inpatients from Central Defense Hospital “Gómez Ulla”, Madrid, Spain, who were hospitalised for COVID-19 and had a definitive outcome (dead or discharged). We used a statistical survival analysis to detect treatment differences associated with in-hospital death. Results: We analysed first 220 medical records. 166 patients met the inclusion criteria. 48,8 % of patients not treated with HCQ died, 22% of those treated with hydroxychloroquine (p=0,002). According to clinical picture at admission, hydroxychloroquine increased the mean cumulative survival in all groups from 1,4 to 1,8 times. This difference was statistically significant in the mild group. Conclusions: in a cohort of 166 patients from 18 to 85 years hospitalised with COVID-19, hydroxychloroquine treatment with 800mg added loading dose increased survival when patients were admitted in early stages of the disease. There was a non-statistically significant trend towards survival in all groups, which will have to be clarified in subsequent studies.

Subject Areas

COVID-19; treatment; drug; survival; antiviral; hydroxychloroquine

Comments (5)

Comment 1
Received: 12 May 2020
Commenter: Frank Conijn
The commenter has declared there is no conflict of interests.
Comment: Table 2 shows that the D dimer levels at baseline were 558 (HCQ group) versus 1511 (no HCQ group). That is an extreme difference: 558 is quite normal while 1511 is sky-high. How can that have gotten a p value of 0.168? If it's clinically utterly significant, how can it be statistically insignificant? For those who don't know: D dimer is a biomarker that indicates the risk of thrombosis. And there are more and more reports by clinicians who see all kinds of embolisms in Covid patients on the ICUs.
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Response 1 to Comment 1
Received: 12 May 2020
Commenter: Frank Conijn
The commenter has declared there is no conflict of interests.
Comment: Actually, D-dimer is a protein fragment that's released when a clot dissolves. So it in fact indicates that thrombosis is already occurring. And high levels of D-dimer appear to be a powerful predictor of mortality in hospitalized patients with Covid-19. See https://www.nature.com/articles/d41586-020-01403-8.
Response 2 to Comment 1
Received: 13 May 2020
Commenter: Frank Conijn
The commenter has declared there is no conflict of interests.
Comment: This thread is discontinued. Please surf to the page with version 2 of the paper on https://www.preprints.org/manuscript/202005.0057/v2 .
Comment 2
Received: 12 May 2020
Commenter: Francisco Javier Membrillo
The commenter has declared there is no conflict of interests.
Comment: This point is discussed on V2. At the beginning of the pandemic our ER department didn't perform d-dymer at admission, so we most patients didn't have this data and it's interpretation is difficult. Thanks for the feedback
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Comment 3
Received: 12 May 2020
Commenter: Francisco Javier Membrillo
The commenter has declared there is no conflict of interests.
Comment: Totally agree. Unfortunately, at the beginning of the pandemic in Spain our Emergency department didn't test d-dymer systematically. So over half of patients dont' have this data fullfilled. Please revise v2 were we added a paragraph explaining this point. Thanks for the feedback
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