Hydroxychloroquine for COVID-19: Meta-analysis of 197 Studies (February 2021)

By Dr. Frank Yap, MD -

 At-A-Glance:

  • HCQ (Hydroxychloroquine) is not effective when used very late with high dosages over a long period (RECOVERY/SOLIDARITY), effectiveness improves with earlier usage and improved dosing. 
  • Early treatment consistently shows positive effects. 
  • Negative evaluations typically ignore treatment time, often focusing on a subset of late stage studies.

Introduction
We analyze all significant studies concerning the use of HCQ (or CQ) for COVID-19. Search methods, inclusion criteria, effect extraction criteria (more serious outcomes have priority), all individual study data, PRISMA answers, and statistical methods are detailed in Appendix 1. We present random-effects meta-analysis results for all studies, for studies within each treatment stage, for mortality results only, after exclusion of studies with critical bias, and for Randomized Controlled Trials (RCTs) only. Typical meta analyses involve subjective selection criteria and bias evaluation, requiring an understanding of the criteria and the accuracy of the evaluations. However, the volume of studies presents an opportunity for an additional simple and transparent analysis aimed at detecting efficacy.
If treatment was not effective, the observed effects would be randomly distributed (or more likely to be negative if treatment is harmful). We can compute the probability that the observed percentage of positive results (or higher) could occur due to chance with an ineffective treatment (the probability of >= k heads in n coin tosses, or the one-sided sign test / binomial test). Analysis of publication bias is important and adjustments may be needed if there is a bias toward publishing positive results. For HCQ, we find evidence of a bias toward publishing negative results.
Figure 2 shows stages of possible treatment for COVID-19. Pre-Exposure Prophylaxis (PrEP) refers to regularly taking medication before being infected, in order to prevent or minimize infection. In Post-Exposure Prophylaxis (PEP), medication is taken after exposure but before symptoms appear. Early Treatment refers to treatment immediately or soon after symptoms appear, while Late Treatment refers to more delayed treatment.
Results
Early treatment.
 100% of early treatment studies report a positive effect, with an estimated reduction of 66% in the effect measured (death, hospitalization, etc.) from the random effects meta-analysis, RR 0.34 [0.27-0.44].
Late treatment.
 Late treatment studies are mixed, with 73% showing positive effects, and an estimated reduction of 25% in the random effects meta-analysis. Negative studies mostly fall into the following categories: they show evidence of significant unadjusted confounding, including confounding by indication; usage is extremely late; or they use an excessively high dosage.
Pre-Exposure Prophylaxis.
 77% of PrEP studies show positive effects, with an estimated reduction of 36% in the random effects meta-analysis. Negative studies are all studies of systemic autoimmune disease patients which either do not adjust for the different baseline risk of these patients at all, or do not adjust for the highly variable risk within these patients.
Post-Exposure Prophylaxis.
 83% of PEP studies report positive effects, with an estimated reduction of 33% in the random effects meta-analysis.
Results by treatment stage


Randomized Controlled Trials (RCTs)
Randomized Controlled Trials (RCTs) minimize one source of bias and can provide a higher level of evidence. Results restricted to RCTs are shown in Figure 7, Figure 8, and Table 2. Even with the small number of RCTs to date, they confirm efficacy for early treatment. Prophylaxis and early treatment studies show 29% improvement in random effects meta-analysis, RR 0.71 [0.54‑0.94], p = 0.015. Early treatment RCTs show 49% improvement, RR 0.51 [0.30‑0.88], p = 0.015.
Evidence supports incorporating non-RCT studies. [Concato] find that well-designed observational studies do not systematically overestimate the magnitude of the effects of treatment compared to RCTs. [Anglemyer] summarized reviews comparing RCTs to observational studies and found little evidence for significant differences in effect estimates. [Lee] shows that only 14% of the guidelines of the Infectious Diseases Society of America were based on RCTs. Limitations in an RCT can easily outweigh the benefits, for example excessive dosages, excessive treatment delays, or Internet survey bias could easily have a greater effect on results. Ethical issues may prevent running RCTs for known effective treatments. For more on the problems with RCTs see [Deaton, Nichol].
Discussion
Publication bias.
 Publishing is often biased towards positive results, which we would need to adjust for when analyzing the percentage of positive results. Studies that require less effort are considered to be more susceptible to publication bias. Prospective trials that involve significant effort are likely to be published regardless of the result, while retrospective studies are more likely to exhibit bias. For example, researchers may perform preliminary analysis with minimal effort and the results may influence their decision to continue. Retrospective studies also provide more opportunities for the specifics of data extraction and adjustments to influence results.
For HCQ, 87.8% of prospective studies report positive effects, compared to 75.0% of retrospective studies, indicating a bias toward publishing negative results. Figure 10 shows a scatter plot of results for prospective and retrospective studies.
Figure 11 shows the results by region of the world, for all regions that have > 5 studies. Studies from North America are 3.8 times more likely to report negative results than studies from the rest of the world combined, 52.3% vs. 13.7%, two-tailed z test -5.36, p = 0.00000008. [Berry] performed an independent analysis which also showed bias toward negative results for US-based research.
The lack of bias towards positive results is not very surprising. Both negative and positive results are very important given the current use of HCQ for COVID-19 around the world, evidence of which can be found in the studies analyzed here, government protocols, and news reports, for example [AFP, AfricaFeeds, Africanews, Afrik.com, Al Arabia, Al-bab, Anadolu Agency, Anadolu Agency (B), Archyde, Barron's, Barron's (B), BBC, Belayneh, A., Bianet, CBS News, Challenge, Dr. Goldin, Efecto Cocuyo, Expats.cz, Face 2 Face Africa, Filipova, France 24, France 24 (B), Franceinfo, Global Times, Government of China, Government of India, Government of Venezuela, GulfInsider, Le Nouvel Afrik, LifeSiteNews, Medical World Nigeria, Medical Xpress, Medical Xpress (B), Middle East Eye, Ministerstva Zdravotnictví, Ministry of Health of Ukraine, Ministry of Health of Ukraine (B), Morocco World News, Mosaique Guinee, Nigeria News World, NPR News, Oneindia, Pan African Medical Journal, Parola, Pilot News, PledgeTimes, Pleno.News, Q Costa Rica, Rathi, Russian Government, Russian Government (B), Teller Report, The Africa Report, The Australian, The BL, The East African, The Guardian, The Indian Express, The Moscow Times, The North Africa Post, The Tico Times, Ukrinform, Vanguard, Voice of America].
We also note a bias towards publishing negative results by certain journals and press organizations, with scientists reporting difficulty publishing positive results [Boulware, Meneguesso]. Although 153 studies show positive results, The New York Times, for example, has only written articles for studies that claim HCQ is not effective [The New York Times, The New York Times (B), The New York Times (C)]. As of September 10, 2020, The New York Times still claims that there is clear evidence that HCQ is not effective for COVID-19 [The New York Times (D)]. As of October 9, 2020, the United States National Institutes of Health recommends against HCQ for both hospitalized and non-hospitalized patients [United States National Institutes of Health].
Treatment details.
 We focus here on the question of whether HCQ is effective or not for COVID-19. Studies vary significantly in terms of treatment delay, treatment regimen, patients characteristics, and (for the pooled effects analysis) outcomes, as reflected in the high degree of heterogeneity. However, early treatment consistently shows benefits. 100% of early treatment studies report a positive effect, with an estimated reduction of 66% in the effect measured (death, hospitalization, etc.) in the random effects meta-analysis, RR 0.34 [0.27-0.44].
Conclusion
HCQ is an effective treatment for COVID-19. The probability that an ineffective treatment generated results as positive as the 197 studies to date is estimated to be 1 in 768 trillion (p = 0.0000000000000013).
100% of early treatment studies report a positive effect, with an estimated reduction of 66% in the effect measured (death, hospitalization, etc.) using a random effects meta-analysis, RR 0.34 [0.27-0.44].

Appendix 1. Methods and Study Results
We performed ongoing searches of PubMed, medRxiv, ClinicalTrials.gov, The Cochrane Library, Google Scholar, Collabovid, Research Square, ScienceDirect, Oxford University Press, the reference lists of other studies and meta-analyses, and submissions to the site c19study.com, which regularly receives submissions of both positive and negative studies upon publication. Search terms were hydroxychloroquine or chloroquine and COVID-19 or SARS-CoV-2, or simply hydroxychloroquine or chloroquine. Automated searches are performed every hour with notifications of new matches. All studies regarding the use of HCQ or CQ for COVID-19 that report an effect compared to a control group are included in the main analysis. This is a living analysis and is updated regularly.
We extracted effect sizes and associated data from all studies. If studies report multiple kinds of effects then the most serious outcome is used in calculations for that study. For example, if effects for mortality and cases are both reported, the effect for mortality is used, this may be different to the effect that a study focused on. If symptomatic results are reported at multiple times, we used the latest time, for example if mortality results are provided at 14 days and 28 days, the results at 28 days are used. Mortality alone is preferred over combined outcomes. Outcomes with zero events in both arms were not used. Clinical outcome is considered more important than PCR testing status. For PCR results reported at multiple times, where a majority of patients recover in both groups, preference is given to results mid-recovery (after most or all patients have recovered there is no room for an effective treatment to do better). When results provide an odds ratio, we computed the relative risk when possible, or converted to a relative risk according to [Zhang]. Reported confidence intervals and p-values were used when available, using adjusted values when provided. If multiple types of adjustments are reported including propensity score matching (PSM), the PSM results are used. When needed, conversion between reported p-values and confidence intervals followed [Altman, Altman (B)], and Fisher's exact test was used to calculate p-values for event data. If continuity correction for zero values is required, we use the reciprocal of the opposite arm with the sum of the correction factors equal to 1 [Sweeting]. If a study separates HCQ and HCQ+AZ, we use the combined results were possible, or the results for the larger group. Results are all expressed with RR < 1.0 suggesting effectiveness. Most results are the relative risk of something negative. If a study reports relative times, the results are expressed as the ratio of the time for the HCQ group versus the time for the control group. If a study reports the rate of reduction of viral load, the results are based on the percentage change in the rate. Calculations are done in Python (3.9.1) with scipy (1.5.4), pythonmeta (1.11), numpy (1.19.4), statsmodels (0.12.1), and plotly (4.14.1).
The forest plots are computed using PythonMeta [Deng] with the DerSimonian and Laird random effects model (the fixed effect assumption is not plausible in this case).
We received no funding, this research is done in our spare time. We have no affiliations with any pharmaceutical companies or political parties.
We have classified studies as early treatment if most patients are not already at a severe stage at the time of treatment, and treatment started within 5 days after the onset of symptoms, although a shorter time may be preferable. Antivirals are typically only considered effective when used within a shorter timeframe, for example 0-36 or 0-48 hours for oseltamivir, with longer delays not being effective [McLean, Treanor].
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By Dr. Frank Yap, MD -
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Ivermectin has proven more effective than chemotherapy, without any of the debilitating side-effects, according to world-renowned Canadian oncologist Dr. William Makis who cited a major international cancer study to make his case. Dr. Makis asserts that the study’s findings call for a profound shift in the treatment of advanced breast cancer, as the evidence shows Ivermectin could significantly outperform traditional chemotherapy. According to Dr. Makis, the anti-parasitic drug Ivermectin has shown staggering results, outperforming the widely-used chemotherapy drug Paclitaxel and destroying cancer stem cells — those responsible for metastasis and recurrence. Dr. Makis based his urgent plea on a 2017 study by Mexican researchers, which should have fundamentally changed breast cancer treatment. Published as “Ivermectin as an Inhibitor of Cancer Stem Cells,” the study reveals how Ivermectin annihilates breast cancer stem cells, offering new hope for patients battling advanced stag...
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Fenbendazole: Questions Answered, Things to Know, Useful Tips - Ben Fen

By Dr. Frank Yap, MD -
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Readers ask a variety of questions regarding the use of fenbendazole. This article is mainly a result of those questions and has been in the hopper for quite a while. It is long overdue as it contains items of importance that, if we waited for the appropriate thematic venue to publish them, they might never see the light of day. With that in mind, please accept the following for what it is: a hodgepodge of fenbendazole-related items that are very important to know. Incorporate these bits and pieces into your arsenal of ideas regarding fenbendazole, any unique insights that come to mind please feel free to share. How Safe is Fenbendazole? Is fenbendazole harmful to humans? Due to the long and successful use of fenbendazole as a veterinary antiparasitic medicine since the late 1950s, a wealth of safety data has been acquired that has stood the test of time. According to Drugs.com, there are no commonly used drugs that interact with fenbendazole. Fenbendazole is so safe for veterinary con...
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12 Types of Zinc Supplementation and Absorption 2024

By Dr. Frank Yap, MD -
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Zinc is a powerful immune nutrient known for its benefits for providing immune health support and anti inflammation as well as for improving cold and respiratory symptoms, wound healing, acne reduction, and lowering the risk of age-related diseases. Research on atherosclerosis and diabetes mellitus suggests that zinc deficiency may contribute to low-grade systemic inflammation. Types of Zinc What's the best absorbed zinc supplement form?  We know there’s an ocean of information out there to navigate, so we’ve compiled a list of common zinc types and an overview on each zinc type below. There are several types of zinc supplements. Supplements contain several forms of zinc, including zinc gluconate, zinc citrate and zinc picolinate. The percentage of elemental zinc varies by form.  Choosing a zinc supplement can be confusing because there are so many different types. zinc acetate zinc an...
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FENBENDAZOLE in Stage 4 Cancers - the 2021 Stanford University Case Series

By Dr. Frank Yap, MD -
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What is the "Stanford Fenbendazole Protocol"? I bet you've never heard of the "Stanford Fenbendazole Protocol" for treating Cancer. Yet, it exists. But it's heavily suppressed by search engines and mainstream Oncology, especially in the United States and Canada. In 2021 a group at Stanford University Medical Center, Department of Medicine, published a Case Series (Clin. Oncol. Case Rep 2021)* on a "forbidden" repurposed drug, Fenbendazole. *Note: Clinical Oncology Case Reports is a peer-reviewed International clinical and medical oncology and cancer research Journal. Clinical Oncology Case Reports (COCR) is a high-impact multidisciplinary journal focus on the area of clinical and medical investigation. They wrote about 3 cases of Stage 4 Cancer patients who self-treated and cured their cancers.   Case 1: 63 year old man with a Stage 4 Renal Cell Carcinoma (clear cell) , a 5.3cm mass and mets to pancreas and bone, failed 3 lines of chemo. He ac...
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FENBENDAZOLE and CANCER: "15 Minutes with Dr. William Makis"

By Dr. Frank Yap, MD -
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Transcription (emphasis 2SG - 2nd Smartest Guy):  Hi, everyone. Welcome to another episode of 15 minutes with Dr. Makis, my new hard hitting medical podcast. This episode is about  fenbendazole  and cancer.  I will give you the most comprehensive review of the use of  fenbendazole  in cancer there is.   Fenbendazole  is an antiparasitic.  It is a dog dewormer, has been used It's been used as an antiparasitic since the 1960s,   and it has been shown to have extensive anti cancer activity.    Now, it's not FDA approved for use in humans. There is a version of it that is almost identical that is approved for use in humans by the FDA, and it's called mebendazole. (2SG: Mebendazole is BigPharma’s money grab whereby they removed a molecule from fenbendazole such that they could egregiously up-charge for a slightly inferior compound based on a bogus patent). I will do a separate video for mebendazole because the...
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Fenbendazole for Humans: Safety and Efficacy Examined (2024)

By Dr. Frank Yap, MD -
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Fenbendazole is a broad spectrum anthelmintic used against gastrointestinal parasites including: giardia, roundworms, hookworms, whipworms, the tapeworm genus Taenia (but not effective against Dipylidium caninum, a common dog tapeworm), pinworms, aelurostrongylus, paragonimiasis, strongyles, and strongyloides that can be administered to sheep, cattle, horses, fish, dogs, cats, rabbits, most reptiles, freshwater shrimp tanks as planaria and hydra treatments, as well as seals. ( Wikipedia )  Fenbendazole, has garnered ⁤attention​ for its potential use ​in‍ humans.‍ The Fenbendazole Cancer Protocol gained rapid interest over the past years following some fenbendazole advanced cancer success stories . Joe Tippens founded the protocol  after he was told a story about a scientist at Merck Animal Health that had been performing cancer research on mice. The research included injecting different types of cancers into different mice body parts. The ...
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Is a combination of Fenbendazole and Ivermectin a real cancer killer?

By Dr. Frank Yap, MD -
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Fenbendazole and/or Mebendazole seem the perfect pairing with Ivermectin as an off label combination against cancer; recent research shows this 3-in-1 combination attacks the mitochondrial stem cell connection. I am increasingly asked by cancer patients about the combination of anthelmintic Fenbendazole and Ivermectin against cancer. Importantly, these patients aren’t the usual stage 2 cancer patients for whom conventional medicine still has a long way to go. These belong to two distinct groups. First, there are older men whose lung cancer or prostate cancer has returned and they feel that conventional medicine (which they had before) didn’t work before, so why would it work next time. They subscribe to Einstein’s definition of insanity - doing the same thing over and over again and expecting a different result. Secondly, and this is an equally big group of patients - under 40s with rampant breast cancer, colorectal cancer or lymphoma - the 'early onset' cancer victims. Yes, I ...
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