Hydroxychloroquine for Pre-Exposure Prophylaxis for Sars-Cov-2

Abstract

SARS-CoV-2 infection has a high transmission level. At the present time there is not a specific treatment approved but it is known that, in vitro, chloroquine and hydroxychloroquine can inhibit the coronavirus. Objective: verifying if patients with autoimmune diseases that are on treatment with HCQ have less incidence and severity on COVID-19. Material and methods: this is a retrospective cohort study. The exposed cohort was formed by individuals with autoimmune diseases with HCQ treatment. The control cohort was randomly selected using the Health Card database. To deal with confounding variables and evaluate the effect of HCQ on the incidence and severity of SARS-CoV-2 infection, propensity score matching was used. Risk difference and paired percentage difference between exposed and non-exposed groups was estimated. Results: 919 individuals formed the exposed cohort and 1351 the control cohort. After matching, there were 690 patients on each group. During the time of the study, in the exposed group there were 42 (6.1%) individuals with suspected COVID-19, 12(1.7%) with confirmed COVID-19 and 3(0.4%) were hospitalized. In the control group there were 30(4.3%) individuals with suspected COVID-19, 13(1.9%) with confirmed COVID-19 and 2(0.3%) were hospitalized. The risk difference between each cohort was: 0.017(-0.05-0.04) for suspected COVID-19; -0.014(-0.015-0.012) for confirmed COVID-19 and 0.001(-0.007-0.007) for hospitalized patients. There were not significant differences. Conclusion: there is no difference neither on the incidence nor on the severity of COVID-19 between patients with autoimmune diseases with HCQ treatment and patients that do not take HCQ. Strengths and limitations of this study Strenghts: Ii provides evidence on pre-exposure prophylaxis of HCQ against COVID-19 for which there is still no evidence in clinical trials. The study on the pre-exposure prophylaxis of HCQ was carried out during the period of maximum circulation of SARS-COV-2 in Spain. Therefore, both cohorts had a high probability of exposure to the virus, which increases the power of the study. The dose of HCQ taken by most of the study subjects (400 mg per day) is similar to that used in several clinical trials that are underway as pre- and post-exposure prophylaxis of COVID-19. Limitations: The population of the exposed group suffers entirely from rheumatic diseases. This condition could act as a confounding factor, making it difficult to generalize the results to the entire population. Propensity score matching resulted in a reduction in sample size. Of the 900 initial couples, only 690 survive. Given the shortage of diagnostic tests during the study period, many of the possible COVID-19s were left unconfirmed, limiting the power of the study.

SciScore for 10.1101/2020.08.31.20185314: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

NIH rigor criteria are not applicable to paper type.

Table 2: Resources

No key resources detected.

Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

There are several limitations in our study. This is a retrospective study that analyzes real-life data of two groups, treatment and control, whose basal characteristics were not comparable. To overcome this limitation PSM was needed. The size of our sample was reduced because it was not possible to match some individuals. The estimated number of matches needed to achieve a correct output for the hypothesis tests was 900. Neverthless, after matching, sample size was reduced to 690 patients per group. However, we end up with two comparable groups where the only difference was treatment status before exposure. In Spain most COVID-19 cases were not severe and therefore were well managed by General Practitioners from Primary Care. At the beginning of the pandemic there were not enough diagnostic tests, hence they were mostly used for hospitalized patients. This is the reason why a considerable number of suspected COVID-19 patients were not confirmed. Of 72 suspected individuals only 25 were confirmed with SARS-CoV-2 infection. The 47 remaining, exposed and non-exposed, were not confirmed. If we would have been able to perform diagnostic tests maybe the confirmed patients would have inclined the balance to either the exposed group or to the non-exposed group. Having used a pragmatic approach made it easier to recruit the exposed cohort but it made it more difficult to apply these results to general population. All the individuals in the exposed group had rheumatic diseases. This co...

Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

Identifier	Status	Title
NCT04333225	Completed	Hydroxychloroquine in the Prevention of COVID-19 Infection i…
NCT04331834	Completed	Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Ri…

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

Results from rtransparent:

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Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
No protocol registration statement was detected.

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Hydroxychloroquine for Pre-Exposure Prophylaxis for Sars-Cov-2

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