Efficacy of Subcutaneous Ivermectin With or Without Zinc and Nigella Sativa in COVID-19 Patients (Pakistan 2020-07-15)

[-] TrumpLyftAlles | 2 points | Jul 16 2020 00:26:00

This is the 33rd ivermectin vs covid-19 study registered at ClinicalTrails.

Official title:

Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc and Nigella Sativa: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients

Detailed description:

This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demostrate the antiviral effects of subcutaneous Ivermection with or without zinc and Nigella sativa. in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..

N=40 patients tested positive for the virus, randomly assigned to 4 arms:

Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 80mg/Kg/day Nigella Sativa plus standard care
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
Placebo drug plus standard care

Primary outcome measures:

time needed to turn positive COVID-19 PCR to negative
time needed to make patients clinically better

Start date: 2020-07-14
Primary completion: 2020-09-15
Study completion: 2020-09-30

Thoughts:

IIRC, this is the first trial looking at sub-cutaneous injection of ivermectin. I haven't read about any sub-cutaneous injection of the drug in humans. It's been studied for cattle, IIRC. Medincell is a French company with backing from the Gates foundation which since February has been putting out press releases about its plans to test their sub-cutaneous gadget that secretes ivermectin, to prevent catching the virus. AFAIK Medincell hasn't actually done anything.

Nigella Sativa is a plant that is believed to have therapeutic benefits. There are two other trials (in addition to this one) looking at the plant's efficacy against covid-19. See A review on therapeutic potential of Nigella sativa: A miracle herb. It has a long list of benefits. Apparently it's not anti-viral, but it may protect the lungs. A quick scan of the article didn't reveal anything else covid19-related.

Zinc Sulphate is a favored form of zinc for prophylaxis and treatment of covid19 among HCQ advocates. Again, there are 2 clinical trials besides this one looking at this zinc, possibly not this variety.

The N=10 for each branch is probably too few to yield statistically-significant results. Why so few? Not enough covid19? Pakistan is getting a couple thousand new cases / day, but it's a big country. The study is being conducted in Lahore, which only has half-a-percent of Pakistan's population.

The expected September completion date is good news.

Also posted to /r/covid19.

[-] stereomatch | 2 points | Jul 16 2020 04:00:58

Nigella Sativa is a plant that is believed to have therapeutic benefits.

Nigela Sativa is called "black caraway" or "kalonji":

https://en.wikipedia.org/wiki/Nigella_sativa

Oils are 32% to 40% of the total composition of N. sativa seeds.[4][15] N. sativa oil contains linoleic acid, oleic acid, palmitic acid, and trans-anethole, and other minor constituents, such as nigellicine, nigellidine, nigellimine, and nigellimine N-oxide.[4] Aromatics include thymoquinone, dihydrothymoquinone, p-cymene, carvacrol, α-thujene, thymol, α-pinene, β-pinene and trans-anethole.[4] Protein and various alkaloids are present in the seeds.[4]

It seems to have a history of use for dyspnea ie shortness of breath:

The Persian physician Avicenna in his Canon of Medicine described N. sativa as a treatment for dyspnea.[13]

From the link for nigela sativa you mentioned:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3642442/

It seems nigela sativa contains thymoquinone:

This is also revealed that most of the therapeutic properties of this plant are due to the presence of thymoquinone which is major bioactive component of the essential oil. The most important active compounds are thymoquinone (30%-48%), thymohydroquinone, dithymoquinone, p-cymene (7%-15%), carvacrol (6%-12%), 4-terpineol (2%-7%), t-anethol (1%-4%), sesquiterpene longifolene (1%-8%) α-pinene and thymol etc.

Interestingly may have use for H. Pylori (cause of many stomach ulcers) - as an alternative to conventional antibiotic treatment (antibiotics usually affect gut microbiome balance):

Antibacterial activity of N. sativa against and triple therapy in eradication of Helicobacter Pylori in patients with non-ulcer dyspepsia was carried out. It was showed that N. sativa seeds possess clinically useful anti H. pylori activity, comparable to triple therapy[28].

But what dose to use the seeds at - to provide sufficient dose of the bioactive compounds in it?

There seems to be an estrogenic impact of nigela sativa - which is interesting, as estrogen seems to have a protective impact in covid19:

The ethanolic extract of N. sativa seeds was found to possess an anti-fertility activity in male rats which might be due to inherent estrogenic activity of N. sativa

[-] TrumpLyftAlles | 2 points | Jul 16 2020 04:14:31

Wow, thanks for all that information!

There seems to be an estrogenic impact of nigela sativa - which is interesting, as estrogen seems to have a protective impact in covid19

Good motivation to learn more, thank-you.