Clinical Trials are the foundation on which clinical medicine practice stands after thorough research and intensive experiments. Starting with small animals like rat/mouse, clinical trials ultimately reach the stage of experimenting with human subjects to evaluate the efficacy of novel diagnostic or therapeutic research products. Clinical trials are usually classified under four different phases (Phase I-IV) based on the number of participants in the trial study, but there are other Observational or Interventional ways. With the explosion of COVID-19 awareness and management, as per the national clinical trials registry, 82 trials have been registered till date in India. Let us discuss some of the major trials against COVID-19.
In India, Glenmark has initiated a randomized clinical trial (CTRI/2020/05/025114) across 9 hospitals to test the efficacy of Favipiravir (a Japanese Influenza drug)for the shedding of the coronavirus load in patients.Besides that, India also performs multicenter clinical trial evaluating a range of antiviral therapeutics like Remdesivir and Lopinavir/Ritonavir (CTRI/2020/04/024773).
Clinical trials against COVID-19 in India are dominated by drugs like Chloroquine and Hydroxychloroquine. Such trials have been seen in Kerala, Karnataka, Tamil Nadu, and Delhi. Very interestingly, National Cancer Institute, in Pune, has registered a trial to repurpose 0.03% Chloroquine eye drops as nasal drops to test for reducing viral load with enhanced bioavailability (CTRI/2020/04/024729). Anti-helminthic drugs like Ivermectin and Niclosamide are also being evaluated across different hospitals in India although their action mechanism against COVID-19 is inconclusive and unclear. South Korea has been leading the repurposing research for anti-helminthic drugs in COVID-19 situation and some private hospitals have also initiated these clinical trials.
The BCG vaccine has been reported to show non-specific immunomodulatory effects and thus has also been used in cancer immunotherapy and against viral infections (Curtis et al, Lancet, 2020). It has been reportedly shown that countries with BCG vaccine immunization had less COVID-19 cases. Although such weak evidence from epidemiological reports might be a correlation, several countries like Australia and Netherlands are studying the effects of BCG against COVID-19. Amidst these global trials, India has already initiated 3 BCG clinical trials (CTRI/2020/04/024749; CTRI/2020/04/024846; CTRI/2020/05/025013).
Convalescent plasma, the blood plasma extracted from a recovered patient’s blood is rich in antibodies against the disease. Previously used for H1N1 and SARS-CoV, convalescent plasma therapy is now widely used in trials worldwide against COVID-19. India has initiated widespread clinical trials approved by ICMR and deems it as a successful and promising approach.
Alternative Herbal Medicines
India has a vast resource of medicinal plants and herbs and based on the knowledge of traditional indigenous herbs, the govt. has a dedicated wing for Ayurvedic, Unani, Siddha, and Homeopathic (AYUSH) research. Thymoquinone is one of the major constituents of Nigella sativa (Black Cumin/ “Kala-jeera”) and is reported to have possible immunomodulatory effects. Intas pharmaceuticals is supporting a non-randomized clinical trial in Gujarat for COVID-19 patients to evaluate the therapeutic potential of Thymoquinone. (CTRI/2020/05/025167). Besides that, randomized open-labeled clinical trials of Chawanprash are initiated by Dabur (CTRI/2020/05/024981), and the Ministry of AYUSH, Govt. of India has launched a randomized open-labeled clinical trial of Ashwagandha against COVID-19 (CTRI/2020/05/025166).
However, most of these clinical trials lack adequate and conclusive in vitro or preclinical data and presents little clarity on the mechanism of action. Hence, in the COVID-less world, many of the clinical trials would not have been approved. However, drastic times call for drastic measures and we have to encourage better therapeutics against COVID19.
Advancellsgroup: Corona Protection Kit