Advanced Mediterranean Diet

Remdesivir and hydroxychloroquine don’t do much good for hospitalized COVID-19 patients, according to this abstract of the SOLIDARITY trial:

BACKGROUND

World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19).

METHODS

We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.

RESULTS

At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.

CONCLUSIONS

These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.

Steve Parker, M.D.

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From Diabetes Metab Syndr in Sept 2020:

The clinical efficacy and utility of ivermectin in SARS CoV-2 infected patients are unpredictable at this stage, as we are dealing with a completely novel virus. However, repurposing existing drugs as possible COVID-19 treatment is astute usage of existing resources, and we await results of well-designed large scale randomized controlled clinical trials exploring treatment efficacy of ivermectin to treat SARS-CoV-2.

The authors of this letter mention current clinical trials (~38) with a dose [presumably by mouth] ranging from 200 to 1200 mcg/kg body weight, for a duration of 3–7 days, which is showing promising results both in terms of symptoms as well as viral load reduction. Another article mentioned the usual treatment dose is 0.2mg/kg on day 1 and day 3 followed by Days 6 and 8 if not recovered.

The authors cite the Broward Health hospital system study from South Florida. In this small pilot study, hospitalized patients treated with ivermectin had a better survival rate compared with “standard care,” whatever that was back in Spring 2020. The ivermectin-treated patients received “at least one dose” of the drug at 200 mcg/kg, by mouth. Has this report been peer-reviewed and published yet? If not, why not? (Update on Sept 3, 2021: the article was published in Chest in Oct 2020. The protocol was a single dose of ivermectin 200 microgram/kg by mouth, presumably early in hospitalization, with a second dose seven days later at the discretion of the physician.)

Moving on…

One small study (probably 60 each in the treatment and placebo groups) found that 12 mg ivermectin by mouth once a month impressively protected healthcare workers against COVID-19.

Another study: “Two-dose ivermectin prophylaxis at a dose of 300 μg/kg with a gap of 72 hours was associated 73% reduction of COVID-19 infection among [hospital] healthcare workers for the following one-month. Further research is required before its large scale use.”

After hydroxychloroquine, azithromycin, and ivermectin, will nitazoxanide be the next panacea? You heard it first here!

A small study in Barcelona found no benefit from a single standard dose (200 mcg/kg) of ivermectin in patients hospitalized with severe disease. They suggest that a higher dose might be useful.

I’ve spent about 90 minutes on my day off trying to figure out if I should prescribe ivermectin to my hospitalized patients. My conclusion is that we need more and better data before it’s ready for prime time. I agree with Dr Ananda Swaminathan, who probably spent many hours more on the subject:

Evidence for the use of Ivermectin is based on in vitro [lab studies, not living animals], prophylaxis, clinical, safety, and large-scale epidemiologic studies (heterogenous populations in multiple different settings) BUT…

Many of the trials thus far are methodologically flawed without enough information about baseline demographics, multiple primary outcomes, soft/subjective outcomes, convenience samples, and unclear definitions, just to name a few

Additionally, a valid concern in evaluating the literature is that many of the trials have not yet passed the peer review process and are in pre-print format

Although Ivermectin is cheap, readily available, with a fairly safe side effect profile, based on the evaluation of the literature above, at this time, Ivermectin should not be recommended outside of a clinical trial to ensure we get a true answer of effect

Ivermectin is interesting, there is certainly signal to evaluate further, but in our desire to want a treatment option, let’s not continue to do the same thing over and over again, as we saw play out with Hydroxychloroquine

Like they say, “more studies are needed.”

Steve Parker, M.D.

PS: Something you can do to help prevent and survive COVID-19 is to get and stay as healthy as possible. Let me help:

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