In China and India, there are also trials registered to study Traditional Chinese Medicine (TCM) and nutraceutical formulations.
According to one of the largest clinical trial databases, ClinicalTrials.gov from the US, there are 657 registered trials related to COVID-19 as of April 20.
This does not include another 215 trials related to the term ‘SARS-CoV-2’, 33 studies related to the term ‘2019-nCoV’, 18 studies on ‘2019 novel coronavirus’, and 15 studies on ‘severe acute respiratory syndrome coronavirus 2’.
It should be noted that some of these trials are not yet recruiting or have even withdrawn.
NutraIngredients-Asia also found relevant trials from India’s and Australia’s clinical trials registries.
The following is the list of registered clinical trials from different countries in using dietary supplements, health foods, and traditional medicines in fighting COVID-19.
India: Nutraceutical formula (Not yet recruiting)
A group of Indian researchers will be studying the effects of a nutraceutical formula made by the company Shreepad Shree Vallabh (SSV) Phytopharmaceuticals.
While the exact formulation to be studied is not specified, the records showed that the intervention used is a type of nutraceutical. A check on the company shows that it specialises in the development of products based on traditional Indian medicines. NutraIngredients-Asia has reached out to the researchers for details.
The trial will involve individuals who are under quarantine due to recent contact history with COVID-19 patients, and those who are experiencing symptoms, such as cough, fever, and difficulty in breathing.
The purpose is to find out if the SSV formula could enhance the immune system.
The trial, registered on the Clinical Trials Registry India (CTRI) on Apr 15, will be conducted by researchers from the Niphad Sub District Hospital, located at Maharashtra.
Thirty male and female subjects between 18 and 80 years old will be recruited.
Those in the intervention group will consume a SSV tablet (500mg) twice per day immediately after meals for 15 days.
The primary study outcomes measured include improvements in axillary temperature, respiratory rate, pulse, and COVID-19 symptoms.
Secondary study outcomes include measuring the levels of pro-inflammatory cytokines IL-6 and TNF-alpha from the baseline to the end of the intervention.
China: TCM (Recruiting)
TCM is now recognised as part of the COVID-19 standard therapy.
Last week (April 15), the Chinese government announced that three patented TCM formulas – Jinhua Qinggan granule, Lianhua Qingwen capsule, and Xuebijing injection – were clinically effective in treating COVID-19.
Meanwhile, more clinical trials have surfaced to test the efficacy of other TCM.
In a trial sponsored by Jiangsu Famous Medical Technology and registered on Clinicaltrials.gov, scientists will test a concoction of different TCM ingredients.
It is expected to enrol 340 subjects between 18 and 75 years old. The control group will undergo Western medicine treatment, including antiviral drugs and routine treatment. The intervention group will receive both TCM and Western medicine.
The TCM include 11 herbal ingredients such as huoxiang (15g), suye (15g), cangzhu (15g), jinyinhua (15g) etc in the early stage.
At a later stage of the trial, the TCM formulation will change to 15 other ingredients, such as zhimahuang (9g), huangqi (20g), xingren (10g).
The primary study outcomes are the relief or disappearance rate of main COVID-19 symptoms, while the secondary outcomes include the incidence of complications, andthe number of severe and critical conversion cases.
Earlier on, we also reported that other TCM formula, Qing Fei detoxification decoction mixture, Liushen, and maxing shigan powder are being tested for their clinical efficacy.
Australia: High-dose intravenous zinc (Not yet recruiting)
In Australia, Austin Health hospital will conduct a trial on the use of high-dose intravenous zinc as an adjunctive therapy in COVID-19 critically ill patients.
The randomised controlled trial was registered on The Australian New Zealand Clinical Trials Registry (ANZCTR) on April 8.
The study hypothesised that zinc will reduce the severity of COVID-19 infection and improve the clinical outcomes of patients.
In response to queries from NutraIngredients-Asia, the Therapeutic Goods Administration (TGA) said that it has received numerous enquiries about the initiation of new trials for the prevention and treatment of COVID-19.
However, as of April 15, it said that it has not yet received any clinical trial notifications solely involving the use of a dietary supplement to treat or prevent COVID-19.
Egypt: Natural honey (Not yet recruiting)
In Egypt, researchers from the Misr University for Science and Technology are trialling natural honey in the treatment of COVID-19 patients via a randomised, multicentre, double-armed and controlled study.
“Honey has been previously considered as an alternative for acyclovir in the treatment of herpes simplex virus 1 (HSV-1) and it also demonstrated for its significant antiviral effect against varicella zoster virus (VZV).
“Many studies have demonstrated the broad-spectrum antimicrobial effect of honey as an antibacterial, anti-fungal, antiviral and antimycobacterial,” according to the information that the authors have listed on ClinicalTrials.gov.
Aiming to enrol 1,000 patients, the intervention group will receive standard care and natural honey in the dose of 1gm/kg/day divided into two to three doses for 14 days, while the control group will only receive standard care.
The primary outcomes measured included the days for recovery – calculated based on the days from fever to no fever, and lung inflammation recovery in x-ray or CT.
The study design, however, did not explicitly state the kind of natural honey that will be used. NutraIngredients-Asia has contacted the principal investigator Dr Mahmoud Tantawy for comments.
Saudi Arabia: EPA, GLA, antioxidants (Not yet recruiting)
The King Saud University will conduct a double-blind controlled trial on the use of an anti-inflammatory and anti-oxidant oral nutrition supplement (ONS) on COVID-19 patients.
This is a phase 4 trial where 30 patients will be enrolled and undergo the trial for 14 days.
The ONS is enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants.
Specifically, it will contain the following micronutrients: 1.1 g of EPA, 450 mg of DHA, 950 mg of GLA, 2840 IU of vitamin A as 1.2 mg β-carotene, 205 mg of vitamin C, 75 IU of vitamin E, 18 ug of selenium, and 5.7 mg of zinc.
In addition, the ONS include macronutrients such as 14.8g of protein, 22.2g of fat, 25g of carbohydrate (355 kcal).
The control group will have the same macronutrient composition, calorie density, and normal concentrations of vitamin A, C, E, selenium and zinc.
The main biochemical parameters measured include the serum ferritin level, cytokine storm parameters (interleukin-6, tumor necrosis factor-α, and monocyte chemoattractant protein 1), c-reactive protein, and total leukocyte count etc.
“It is expected that the anti-inflammatory-antioxidant ONS might help in the reduction of the COVID-19 severity with more preservation of the nutritional status of infected cases,” according to the researchers.
Trials in US, Europe
Further afield in the US and Spain, there are clinical trials that plan to study the role of micronutrients and even resistant potato starch.
For example, the Yale University will collaborate with the University of Michigan and the University of Minnesota evaluate the efficacy of resistant potato starch in reducing the rates of hospitalisation and improving time to clinical recovery in non-hospitalised COVID-19 patients.
The resistant potato starch used is from the brand Bob’s Red Mill.
“Resistant potato starch (RPS) has been shown to decrease IL-6 in humans, partly through its ability to increase butyrate levels.
“Butyrate not only reduces IL-6 production and overall inflammation, but also has been shown to specifically decrease lung inflammation in animal models through cytokine suppression. Further, it may reduce ACE2 receptor expression, which is the main entry mechanism for COVID-19 into epithelial lung cells,” according to the researchers.
On the other hand, ProgenaBiome, a genetic sequencing lab in the US, will test whether the intake of hydroxychloroquine, vitamin C, D, and zinc can prevent COVID-19.
This will be conducted on medical workers who are exposed to COVID-19.
In Spain, the Universidad de Granada will investigate if the use of vitamin D can improve the health status in 200 non-severe symptomatic COVID-19 patients.
