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0 0.5 1 1.5 2+ Hospitalization -4% Improvement Relative Risk Case -27% Case (b) -23% Case (c) -10% Case (d) 1% Case (e) 19% Barnabas et al. NCT04328961 HCQ RCT PEP Is post-exposure prophylaxis with HCQ beneficial for COVID-19? RCT 829 patients in the USA More cases with HCQ (not stat. sig., p=0.33) Barnabas et al., Annals of Internal Medicine, doi:10.7326/M20-6519 Favors HCQ Favors control
Hydroxychloroquine for Post-exposure Prophylaxis to Prevent Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Trial
Barnabas et al., Annals of Internal Medicine, doi:10.7326/M20-6519, NCT04328961 (history)
Barnabas et al., Hydroxychloroquine for Post-exposure Prophylaxis to Prevent Acute Respiratory Syndrome Coronavirus 2.., Annals of Internal Medicine, doi:10.7326/M20-6519, NCT04328961
Dec 2020   Source   PDF  
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Early terminated PEP RCT comparing HCQ and vitamin C with 781 low-risk patients (83% household contacts), reporting no significant differences.
Different results were reported at IDWeek from the AIM results.
The study enrolled people with their last exposure within 4 days, i.e., if someone was exposed for 30 days in a row, they could be enrolled anywhere from day 1 to day 34. Therefore many were likely infected earlier than the enrollment date. Note that PCR has a very high false negative rates, e.g., 100% on day 1 and 67% on day 4 here [].
50% of infections were detected by day 4. With the PCR false negatives and treatment delays it is likely that a majority of infections happened before enrollment or before HCQ can reach therapeutic levels.
Significantly more cases were caught at baseline in the control group (54 vs. 29 for HCQ) and excluded from analysis.
The early presentation stated that therapy started one day after enrollment and study supplies were sent to the participant "either by courier or mail". The published paper changes this to "courier delivery within 48 hours".
Overall delays are unclear but may be:
time since first exposure - unlimited
time from last exposure to enrollment - 10% reported as >= 5 days
time to telehealth meeting - 1 day (3 days if Friday enrollment?)
time to receive medication - <48 hours (including weekends?)
Symptomatic in this study was based on CDC-defined symptoms which contain symptoms that may be due to HCQ side effects.
Some results have not been reported, including symptomatic @28 days. The study uses a low dosage over an extended period, therapeutic levels may only be reached nearer to day 14, if at all, so day 28 results should be more informative when available (although labeled a PEP trial, with the low dosage and continuous exposure for most participants it is more of a PrEP/PEP trial where benefit might be seen later as HCQ levels increase).
Endpoints were:
Primary outcomes:
PCR+ @28 days mITT - aHR 1.16 [0.77-1.73]
PCR+ @14 days mITT - aHR 1.10 [0.73-1.66] IDWeek report was different: aHR 0.99 [0.64-1.52]
PCR+ @14 days ITT - aHR 0.81 [0.57-1.14]
Secondary outcomes:
PCR+ symptomatic @28 days - NOT REPORTED YET
duration of shedding - NOT REPORTED YET
Not in study protocol:
PCR+ cumulative symptomatic @14 days - aHR 1.23 [0.76-1.99].
Dose in first 24 hours - 0.8g (compare with Boulware et al. 2g)
Dose in first 5 days - 1.6g (compare with Boulware et al. 3.8g)
Other research suggests vitamin C may be beneficial for COVID-19, e.g. []. No information on severity of cases is provided. Binary PCR does not distinguish replication-competence. There were 2 COVID-19 hospitalizations, one in each group. Side effects were similar for HCQ and placebo. 83% medication adherence at day 14.
COVID-19 PEP. NCT04328961 (history).
risk of hospitalization, 3.7% higher, RR 1.04, p = 1.00, treatment 1 of 407 (0.2%), control 1 of 422 (0.2%).
risk of case, 27.0% higher, HR 1.27, p = 0.33, treatment 43 of 353 (12.2%), control 33 of 336 (9.8%), adjusted per study, day 14 symptomatic mITT PCR+ AIM.
risk of case, 23.0% higher, HR 1.23, p = 0.41, treatment 40 of 317 (12.6%), control 32 of 309 (10.4%), adjusted per study, day 14 symptomatic mITT PCR+ IDWeek.
risk of case, 10.0% higher, HR 1.10, p = 0.66, treatment 53 of 353 (15.0%), control 45 of 336 (13.4%), adjusted per study, day 14 PCR+ mITT AIM.
risk of case, 1.0% lower, HR 0.99, p = 0.97, treatment 46 of 317 (14.5%), control 43 of 309 (13.9%), adjusted per study, day 14 PCR+ mITT IDWeek.
risk of case, 19.0% lower, HR 0.81, p = 0.23, treatment 82 of 387 (21.2%), control 99 of 393 (25.2%), NNT 25, adjusted per study, day 14 PCR+ ITT AIM.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Barnabas et al., 7 Dec 2020, Randomized Controlled Trial, USA, peer-reviewed, 30 authors, trial NCT04328961 (history).
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Abstract: ORIGINAL RESEARCH Annals of Internal Medicine Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection A Randomized Trial Ruanne V. Barnabas, MBChB, MSc, DPhil; Elizabeth R. Brown, ScD; Anna Bershteyn, PhD; Helen C. Stankiewicz Karita, MD; Christine Johnston, MD, MPH; Lorna E. Thorpe, PhD, MPH; Angelica Kottkamp, MD; Kathleen M. Neuzil, MD, MPH; Miriam K. Laufer, MD, MPH; Meagan Deming, MD, PhD; Michael K. Paasche-Orlow, MD; Patricia J. Kissinger, PhD, MPH; Alfred Luk, MD; Kristopher Paolino, MD; Raphael J. Landovitz, MD, MSc; Risa Hoffman, MD; Torin T. Schaafsma, MS; Meighan L. Krows, BA; Katherine K. Thomas, MS; Susan Morrison, MD, MPH; Harald S. Haugen, MS; Lara Kidoguchi, MPH; Mark Wener, MD; Alexander L. Greninger, MD, PhD, MS, MPhil; Meei-Li Huang, PhD; Keith R. Jerome, MD, PhD; Anna Wald, MD, MPH; Connie Celum, MD, MPH; Helen Y. Chu, MD, MPH; Jared M. Baeten, MD, PhD; for the Hydroxychloroquine COVID-19 PEP Study Team* Background: Effective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARSCoV-2, potentially permitting its use for prevention. Objective: To test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection. Design: Household-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials .gov: NCT04328961) Setting: National U.S. multicenter study. Participants: Close contacts recently exposed (<96 hours) to persons with diagnosed SARS-CoV-2 infection. Intervention: Hydroxychloroquine (400 mg/d for 3 days followed by 200 mg/d for 11 days) or ascorbic acid (500 mg/d followed by 250 mg/d) as a placebo-equivalent control. hydroxychloroquine group and 334 (422 participants) to the control group. Retention at day 14 was 91%, and 10 724 of 11 606 (92%) expected swabs were tested. Among the 689 (89%) participants who were SARS-CoV-2 negative at baseline, there was no difference between the hydroxychloroquine and control groups in SARS-CoV-2 acquisition by day 14 (53 versus 45 events; adjusted hazard ratio, 1.10 [95% CI, 0.73 to 1.66]; P > 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026). Limitation: The delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days. Conclusion: This rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection. Primary Funding Source: Bill & Melinda Gates Foundation. Measurements: Participants self-collected mid-turbinate swabs daily (days 1 to 14) for SARS-CoV-2 polymerase chain reaction (PCR) testing. The primary outcome was PCRconfirmed incident SARS-CoV-2 infection among persons who were SARS-CoV-2 negative at enrollment. Results: Between March and August 2020, 671 households were randomly assigned: 337 (407 participants) to the A s of 3 December 2020, there have been 64 million reported cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease..
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