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Hydroxychloroquine + Azithromycin Therapy at a Higher Dose Improved Survival by Nearly 200% in Ventilated COVID Patients

AHA Publisher — Mon, 07 Jun 2021 07:00:14 +0000

Dr. Liji Thomas, MD via News-Medical – Treatment options have been limited in the ongoing coronavirus disease 2019 (COVID-19) pandemic. Earlier optimism regarding immunomodulatory drugs such as azithromycin (AZM) and hydroxychloroquine (HCQ) seemed to be undermined by results of large interventional trials. However, a fascinating new study posted to the medRxiv* preprint server (not peer-reviewed*), suggests that such disappointment may have been both premature and unwarranted, based on a re-analysis of over 250 patients on invasive mechanical ventilation (IMV) during the first two months of the pandemic. Using computational modeling, the use of weight-adjusted HCQ and AZM appears to be associated with a more than 100% increase in survival, without a clear correlation with ECG abnormalities. Study Details In this study, based on a subset of critically ill COVID-19 patients, consisting of patients who required intubation and IMV, data from the medical records were analyzed using several novel methods. This included not only the vital signs and laboratory values but the therapeutic methods. The study was carried out on patients at Saint Barnabas Medical Center, New Jersey, with just over 1% having been clinically diagnosed to have COVID-19. Of the 255 patients, almost 80% died during the study period. Seven patients were transferred to another hospital on the ventilator, mostly after day 40 of hospitalization. Parameters were broadly comparable between survivors and non-survivors, except that all patients with an active malignancy, dementia, chronic obstructive pulmonary disease, and stroke failed to survive. However, sex, race, presentation severity, and blood type had no association with survival chances. A pre-print version of the research paper is available on the medRxiv* server. A preprint is a version of a scholarly or scientific paper that precedes formal peer review and publication in a peer-reviewed scholarly or scientific journal. Laboratory Markers Laboratory markers of inflammation, such as Ferritin, D-dimer, Lactate Dehydrogenase (LDH), and C-reactive protein (CRP), were above average in almost every patient (96%). While all parameters, except the LDH, were equivalent in survivors and non-survivors, three patients had D-dimer values above 69,000 ng/mL. LDH values were higher in non-survivors by almost 30%. The increase in these parameters over time was characteristically steeper in patients who did not survive. Clinical Complications More than three in four non-survivors developed acute kidney injury (AKI), of which a tenth received renal replacement therapy (RRT). Of this latter group, a fifth survived. Almost 60% of patients were intubated within three days of hospitalization. The time to intubation did not predict survival, but intubation beyond day 15 was associated with survival in only 1 of 16 patients. More than 90% of the patients in this cohort had high blood glucose levels above 140 mg/dL, peak at >200 mg/dL, without corticosteroid therapy. Although none were known to be diabetics, most probably had impaired glucose tolerance before they acquired SARS-CoV-2. This prevalence is higher than in most other studies, probably because the researchers looked actively for hyperglycemia Obesity While half of the patients were obese, and 30% were overweight, the older patients were significantly heavier. That is, 74% of those above 60 were obese, vs 37% of those below this age. The mean body weight was approximately 90 kg, but unlike most antibiotic clinical trials, the range of body weight was extensive. The heaviest patient thus weighed approximately seven times more than the lightest. Notably, blood glucose levels or obesity did not predict a good clinical outcome. Therapeutic Drugs The chief therapeutic classes included steroids, tocilizumab, convalescent plasma, hydroxychloroquine, and azithromycin. Corticosteroids, when given at 6 mg or more, reduced the mortality risk 1.4 times. Meanwhile, the interleukin-6 receptor blocker) tocilizumab had two-fold lower mortality. Convalescent plasma (CP) was used only from week 4, in a fifth of the patients, mostly younger than those who did not receive it. The survival of the group which received CP was almost doubled from CP non-users. HCQ was used in 94% of patients within 48 hours of emergency room arrival, while >55% received 2,000-3,000 mg, cumulatively. Of this number, approximately 63% also received AZM. This combination fell out of favor over the study period based on external recommendations. Effect of HCQ/AZM on Mortality With every log increase in the cumulative dose of HCQ, the mortality rate fell by 1.12 times, such that at 3 g HCQ, survival odds rose by 2.5 times. When given together with AZM, the benefit was still more significant. Chances of survival increased further. Among those who received both > 3g HCQ and >1g AZM, almost half survived, compared to one in seven (16%) among patients who received one of these drugs at the same dosages. This means a 32% absolute difference in survival, or a relative improvement in survival odds of 200%, with the combination of HCQ/AZM at this dosage. This far exceeds the survival benefit cited in any study of any intervention so far. When HCQ/AZM was given at lower dosages, the risk of death was over three times higher relative to the above combination and dosage regimen. When the cohort was divided into patients who received >3g HCQ/>1g AZM and those who did not, overall, the absolute chances of survival were 23% higher for the first group. The 17% survival in the second group would have increased to 39% with the former treatment, predicted the researchers. This indicates that treatment with >3g HCQ/>1g AZM was associated with a more than 130% increase in survival rate compared to any other standard therapy. Weight-Adjusted Cumulative Dosage The researchers also found that when adjusted for weight, the cumulative dose would have a still greater effect. In fact, the average treatment effect (difference in mean survival, in this case) shows a steep increase between 40-50 mg/kg to peak at 46% for a dose of 82 mg/kg. Thus, patients receiving HCQ above 80 mg/kg of HCQ with >1g AZM had 14 times higher survival odds compared to those who did not. If HCQ dosage was fixed at >3g, the odds of survival were 7 times higher, or less than half of that achieved with the weight-adjusted cumulative dosage. “The fact that weight-adjusted cumulative dose has an even greater effect on survival than cumulative HCQ dose is strong confirmation of the causal relationship between this treatment and improvement in survival rate.” Age was another major factor since those older than 60 were five times more likely to succumb than younger patients. Hyperlipidemia was the single comorbidity linked to approximately four times higher odds of death. Interestingly, there was no correlation between the cumulative dose of HCQ (or AZM) and the occurrence of QTc prolongation. In fact, the QT interval began to fall during the period when the cumulative dose of HCQ increased. None of the patients showed torsades de pointes. What Are the Implications? These findings indicate that a steeply rising ferritin, D-dimer and LDH over time predict poor survival, the rate of rise being several times greater for non-survivors. This should be validated to help provide a better prognosis for COVID-19 patients. The extensive range of obesity among critically ill patients indicates that weight-adjusted dosage is critical in achieving the correct therapeutic levels. Moreover, AZM is an independent contributor to improved survival. Most importantly, this is the first clinical study to demonstrate the remarkable benefit of using cumulative doses of HCQ>3g/AZM>1g, compared to those not treated with this combination. Why did such a large effect miss observation? For one thing, HCQ produces its benefit by cumulative effects on the target cells, which is weight-dependent. The failure to treat patients with weight-adjusted doses leads to ineffective treatment and outcomes biased towards lighter patients. HCQ is both safe and tolerable at higher doses, as shown in studies of rheumatoid arthritis or lupus. Such high doses for such long durations have not been used to treat COVID-19. The earlier studies claiming prolongation of the QTc duration with HCQ in COVID-19 treatment are shown to be flawed. Indeed, available data suggests that this finding is due to the underlying illness itself. The investigators also point out: “On April 24, 2020, the FDA issued a warning about the possible effects of low HCQ on QTc interval (47). Since 2010, the FDA has approved over 150 clinical trials, which include HCQ treatment. The FDA did and does not require monitoring for cardiotoxicity. In each of these trials, the total HCQ dose and expected tissue levels are markedly higher than used or seen in Covid patients. This discrepancy lacks logic or explanation.” In this startling study, the investigators carefully re-examined the data, showing that among critically ill COVID-19 patients on IMV, less than 4% “walk out of hospital.” In contrast, the survival benefit of combined HCQ/AZM at a cumulative dosage of >80 mg/kg and >1g, respectively, is shown to be both clear and significant. The safety at such doses is obvious, since survival is increased by almost 130% in this very high-risk population. Moreover, it appears that AZM is an important component of this therapy in terms of mortality reduction. *Important Notice medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. To read the original article click here.

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Study Suggests Healing Properties of Honey and Nigella Sativa Expedites Viral Clearance in COVID-19 Patients

AHA Publisher — Thu, 12 Nov 2020 08:00:01 +0000

Susha Cheriyedath, M.Sc. via News-Medical Net – The coronavirus disease 2019 (COVID-19) pandemic has impacted over 50 million people so far and has claimed more than 1.25 million lives globally. As the virus continues to spread, with many countries experiencing second waves right now, we still do not have an effective vaccine against COVID-19. This makes finding an effective drug to treat the disease very important, and scientists worldwide are racing against time to find therapeutic solutions that will help treat COVID-19 patients. An ideal treatment would speed up symptomatic recovery, decrease viral load, and expedite viral clearance and reduce mortality. Although certain treatments such as hydroxychloroquine, azithromycin, dexamethasone, remdesivir, antibody therapies, and convalescent plasma have shown some efficacy, an effective treatment to fight severe COVID-19 is still not a reality. Keeping this in mind, a team of researchers from various institutes across Pakistan, Chile, Canada, and the USA recently conducted a clinical trial to investigate the potential effectiveness of a combination of honey and Nigella sativa (HNS) in treating COVID-19 patients. Their study is published on the preprint server medRxiv* prior to the scientific peer review process*. Since previous studies show that both components of HNS have proven anti-microbial, anti-viral, anti-inflammatory, and immune-modulatory effects, the researchers wanted to assess the efficacy of HNS in fighting COVID-19. Healing Properties of Honey and Nigella Sativa Honey has been reported to have beneficial effects against many viruses, including herpes simplex virus (HSV), rubella virus, Hepatitis virus, and Varicella Zoster virus. It is also effective against many multidrug-resistant bacterial strains, especially when used along with antibiotics. In addition to its immunity-boosting effects that stimulate innate as well as adaptive immune responses, honey has been shown to be beneficial in fighting upper respiratory tract infections. Nigella sativa is a medicinal plant commonly known as Black Cumin and has been proven to have anti-viral properties against many viruses, including mouse cytomegalovirus and HCV. In vitro studies have shown that it can decrease the replication of severe acute respiratory syndrome coronavirus (SARS-CoV). Some of its components have a high affinity to many SARS-CoV-2 proteins and enzymes. A Randomized, Controlled Trial to Study the Action of HNS Against COVID-19 The researchers performed a multicenter, randomized, controlled trial in patients with COVID-19 of varying severity. Randomized patients received either a combination of 1 gm/kg/day of honey and 80 mg/kg/day of Nigella sativa or placebo for 13 days. Viral clearance, symptoms, alleviation, and 30-day mortality were some of the outcomes. “The trial results show that the use of HNS in COVID-19 patients promotes viral clearance and reduces the severity of the disease.” Of the 313 patients, part of the study cohort, 210 patients with moderate symptoms and 103 with severe COVID-19 underwent randomization. Among these patients, 107 received HNS, and 103 moderate cases received a placebo. Fifty severe COVID-19 patients were given HNS, and 53 severe cases received placebo. Administration of HNS led to alleviation of symptoms by day 3 in moderate cases and day 7 in severe cases. “Anti-diabetic, anti-hypertensive, cardio-protective and broncho-dilatory properties of HNS make it even more beneficial in diabetic, hypertensive, cardiac and asthmatic patients who have a higher COVID-19 associated mortality.” HNS could be an affordable, home-based, OTC treatment option for COVID-19 patients The study results show that HNS helped with symptoms alleviation and viral clearance and reduced mortality in patients with moderate and severe disease. According to the team, HNS can be used as a safe and effective therapy in COVID-19 patients as it promotes quicker recovery and survival. Thus, they concluded that HNS represents an affordable therapeutic option and can be used alone or in combination with other therapies to fight COVID-19. Some benefits of this potential treatment option are its ‘over the counter’ availability, affordability – less than $5 for the entire treatment course, and ease of administration as it can be a home-based remedy. Moreover, HNS can also be used in combination with other drugs for increased efficacy. The authors believe that this treatment will significantly reduce the burden on global health care systems. “A multinational study with larger sample size is required to investigate potential variations in responses to the treatment in COVID-19 patients from different racial and ethnic origins.” *Important Notice medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. Journal reference: Efficacy of honey and Nigella sativa against COVID-19: HNS-COVID-PK Trial Sohaib Ashraf, Shoaib Ashraf, Muhammad Ahmad Imran, Moneeb Ashraf, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Nighat Majeed, Iqra Farooq, Zaighum Habib, Abubakar Hilal, Zain-ul-Abdin, Ayesha Khaqan, Muhammad Kiwan Akram, Sidra Ashraf, Rutaba Akmal, Sundas Rafique, Khawar Nawaz, Shahroze Arshad, Sohail Ahmad, Kanwal Hayat, Ali Arshad, Muhammad Faisal Nadeem, Muhammad Hassan, Abeer-bin-Awais, Muhammad Azam, Muhammad Suhail, Sibgha Zulfiqar, Imran Anwar, Saulat Sarfraz, Ayesha Hamayoun, Amber Malik, Hui Zheng, Talha Mahmood, Mahmood Ayyaz, Ali Ahmad, Muhammad Ashraf, Qazi Abdul Saboor, Mateen Izhar medRxiv 2020.10.30.20217364; doi: https://doi.org/10.1101/2020.10.30.20217364, https://www.medrxiv.org/content/10.1101/2020.10.30.20217364v2 To read the original article click here.

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