Indian Journal of Pharmacy and Pharmacology

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Indian Journal of Pharmacy and Pharmacology (IJPP) open access, peer-reviewed quarterly journal publishing since 2014 and is published under auspices of the Innovative Education and Scientific Research Foundation (IESRF), aim to uplift researchers, scholars, academicians, and professionals in all academic and scientific disciplines. IESRF is dedicated to the transfer of technology and research by publishing scientific journals, research content, providing professional’s membership, and conducting conferences, seminars, and award programs.

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Biswkarma and Wadhawan: Study of clinical trials for the management of COVID-19 outbreak registered in the Clinical Trial Registry-India


Introduction

On 31st December 2019, Wuhan, China has officially reported the first case of severe acute respiratory syndrome coronavirus (SARS-CoV) to WHO. Which was named as COVID-19 by WHO on 11 February 2020.1 After China, now COVID-19 is spreading all over the world in about 212 countries and territories. More than 3.5 million cases of COVID-19 and 250,000 deaths have been reported to WHO till 7 May 2020.2 In India, over 46008 active, 22454 recovered, 2293 death, and 1 migrated case (a total of 70756 cases) has been reported till 12th May, 2020.3

The use of preventive measures such as social distancing, personal hygiene, use of personal protective equipment, and social awareness plays an important role as to prevent the spread of COVID-19.4 Despite the use of preventive measures, appropriate medical care, symptomatic treatment, and supportive care are an important management option. Several agents such as antiviral drug, immunomodulating biologicals, and hydroxychloroquine proposed to have efficacy against COVID-19.5 Till now, Remdesivir of Gilead is the first antiviral drug has been approved by Japan for the treatment of COVID-19.6, 7

The objective of this study is to review the currently registered clinical studies in Clinical Trials Registry-India. The study provides the overall summary and insight into treatment strategies, diagnostic tools, and preventive strategies for COVID-19.

Materials and Methods

The Institutional Ethics Committee approval was not required for the conduct of the study. All the clinical trials (including clinical studies) registered in Clinical Trials Registry-India ((ctri.nic.in) between 31 March 2020 to 11th May 2020 were reviewed and analyzed. The registered studies were searched in the “Trial Search” option with keywords such as “COVID-19”, “Corona Virus”, “SARS-CoV2”, and “2019 nCoV”. The studies mentioned any of the search keywords in their study title or objective or inclusion criteria were selected for the study. The studies/trials were first categorized in an interventional and observational study and further analysis was done over study design, approval status, subject type to be recruited, recruitment status, etc.

Results

A total of 57 trials over COVID-19 have been registered in CTRI within the last three months (i.e. 1st March 2020 to 11th May 2020). The majority of registered clinical trials/studies are from New Delhi followed by Maharashtra and Uttar Pradesh (Figure 1). These trials include 40 interventional trials and 17 clinical studies. The interventional studies include the drug, biologics, ayurvedic, homeopathic, diagnostic, nutritional, and process of care change (Figure 2). The interventions registered for trials are (a) drug includes Hydroxychloroquine (HCQ), Imatinib, Ivermectin, Ciclesonide, Niclosamide (b) biologics include Convalescent plasma, BCG (c) ayurvedic include Kashaya, ZingiVir H, MyVir tablets, Dabur Chyawanprash, Shanshamani Vati, Yashtimadhu tablet, Guduchi tablet (d) homeopathic include Cadamba drug therapy, Arsenic Album, Bryonia Alba, Gelsemium, Antimonium Tartaricum, Crotalus Horridus (e) diagnostic include Chest X-Ray Artificial Intelligence Module, CT - Scan of Thorax Artificial Intelligence Module, Voice Sampling Artificial Intelligence Module (f) nutritional include SSV formulation and (g) process of care change include Povidone Iodine, Lowest driving pressure guided PEEP. Under trials, these interventions administered either alone or in combination with other drugs and compared with placebo (If applicable), the standard of care, or supportive care (Table 1).

Figure 1

State of trials registration

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Figure 2

Interventional trial

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Most of the observational studies are the prospective type of studies including healthy as well as COVID-19 patients to generate impactful evidence over health, condition diagnosis, prevention, treatment outcomes, and mental status (anxiety, fear of COVID-19) (Table 2).

Table 1

Interventional studies

Interventional-Drug
Reg. IDCTRI/2020/…… Intervention Randomization Blinding Subject Sample Size Recruit-ment Status Estimate Duration (Months) Phase State
03/024402 Grp A: Hydroxy ChloroquineGrp B: Hydroxy Chloroquine (HCQ)-ICMR regimen Yes Open Healthy Human Volunteers 500 Not Yet 3 III Kerala
04/024479 Grp A: Chloroquin PhasphateGrp B: Standard care Yes Open COVID-19 Patients 32 Not Yet 6 NA Karnataka
04/024806 Grp A: Imantinib Oral DrugGrp B: Standard care Yes Open COVID-19 Patients 100 Open 2 II New Delhi
04/024729 Grp A: Topical Nasal 0.03% chloroquine eye drops Grp B: Standard Care Other Open COVID-19 Patients 60 Not Yet 6 II New Delhi
04/024904 Grp A: HCQ high dose (HCQh) ,Hydroxychloroquine sulfate (HCQs) Grp B: HCQ AZT Yes Double COVID-19 Patients 300 Not Yet 12 III Uttar Pradesh
04/024858 Grp A: IvermectinGrp B: Standard treatment as per hospital protocol for COVID 19 No Open COVID-19 Patients 50 Not yet 12 NA New Delhi
04/024948 Grp A: Ciclesonide, Hydroxychloroquine, Ivermectin Grp B: Satandard care of treatment Yes NA COVID-19 Patients 120 Not Yet 6 II New Delhi
04/024949 Grp A: NiclosamideGrp B: Satandard care of treatment Yes NA COVID-19 Patients 48 Not yet 3 II New Delhi
05/025067 Grp A: Hydroxychloroquine along with Standard care Personal protective equipmentGrp B: Standard care Personal protective equipment Yes Open COVID-19 Patients 10990 Not Yet 12 NA New Delhi
04/024773 Grp A: chloroquine or hydroxychloroquineGrp B: Local standard of care, Lopinavir with Ritonavir (ditto) plus Interferon, Lopinavir with Ritonavir (orally twice daily for 14 days) , Remdesivir Yes Open COVID-19 Patients 7000(Global), 1500 (India) Open 12 III Maharashtra
05/024959 Grp A: Best supportive care with ItolizumabGrp B: Standard of care Yes Open COVID-19 Patients 30 Not Yet 3 II Maharashtra
05/025022 Grp A: Hydrooxychloroquine Grp B: Symptomatic treatment Other Open COVID-19 Patients 166 Not Yet 12 II New Delhi
Interventional-Biologics
04/024804 Grp A: Convalescent plasma Grp B: NA Single arm NA COVID-19 Patients 10 Not Yet 3 II Karnataka
04/024915 Grp A: Convalescent Plasma Grp B: Satandard care of treatment Yes Open COVID-19 Patients 100 Not Yet 24 II New Delhi
05/025013 Grp A: BCG plus standard of care as suggested by DCGIGrp B: Saline plus standard of care Yes Single COVID-19 Patients 60 Not yet 3 II Maharashtra
04/024749 Grp A: Recombinant BCG vaccine, VPM1002Grp B: Saline plus standard of care Yes Triple COVID-19 Patients 5946 Not Yet 12 III Maharashtra
04/024706 Grp A: Convalescent Plasma with Supportive Care Grp B: Random donor Plasma with Supportive Care Yes Open COVID-19 Patients 20 Not Yet 3 II New Delhi
04/024846 Grp A: Suspension of heat killed (autoclaved) Mycobacterium wGrp B: Placebo Yes Triple COVID-19 Patients 40 Not Yet 6 NA Gujarat
04/024833 Grp A: BCG-Denmark (Green Signal) Grp B: Placebo Yes Triple Blind Healthy Human Volunteers 1826 Not Yet 12 NA Pondicherry
04/024775 Grp A: Convalescent plasma Grp B: Usual care for COVID-19 disease Yes NA COVID-19 Patients 52 Not Yet 6 II New Delhi
05/024989 Grp A: NA (Genetic Mutation Identification)Grp B: NA Other NA COVID-19 Patients 200 Not Yet 24 NA Telangana
Interventional-Ayurvedic
04/024882 Grp A: kashaya ( Dicoction) of Tinospora cordifoliaGrp B: Standard Care NA NA COVID-19 Patients 30 Not Yet 12 II Haryana
04/024883 Grp A: ZingiVir H Grp B: NA Other Outcome Assessor COVID-19 Patients 112 Open 6 IV Kerala
5/024967 Grp A: MyVir tablets Grp B: Standard treatment as per hospital protocol for COVID 19 Single arm NA COVID-19 Patients 30 Not Yet 6 IV Karnataka
05/024981 Grp A: Dabur ChyawanprashGrp B: Milk Yes Open Healthy Human Volunteer 600 Not Yet 8 NA Rajasthan
05/025069 Grp A: Shanshamani Vati or Sudarshana Ghanavati or Ashwagandha Grp B: NA Single arm Open Healthy Human Volunteers 1324 Not Yet 3 III New Delhi
05/025093 Grp A: Yashtimadhu tabletGrp B: NA Other NA Healthy Human Volunteers 1200 Not Yet 1 Month, 15 days II /III Andhra Pradesh
05/025088 Grp A: Guduchi tabletGrp B: Nil Yes NA Healthy Human Volunteers 1200 Not Yet 6 I/II Andhra Pradesh
Interventional Homeopathic
04/024857 Homeopathy Medicines - Ars Alb, Camphora, Bryonia Alba, Helleborus niger, Justicia Adhatoda. Yes Open COVID-19 Patients 100 Not Yet 1 II Maharashtra
04/024905 Grp A: Homoeopathic Medicine: Arsenic Album, Bryonia Alba, Gelsemium, Antimonium Tartaricum, Crotalus Horridus Grp B: Placebo Yes Single COVID-19 Patients 100 Not Yet 3 III Uttar Pradesh
04/024947 Grp A: Cadamba drug therapy Grp B: NA Yes NA COVID-19 Patients 100 Not Yet 3 III Maharashtra
04/024925 Grp A: Homoeopathic MedicineGrp B: Placebo Yes Open COVID-19 Patients 1000 Not Yet 2 II Maharashtra
04/024926 Grp A: Homoeopathic Medicine: Arsenic Album, Bryonia Alba, Gelsemium, Antimonium Tartaricum, Crotalus Horridus Grp B: NA Single arm Single COVID-19 Patients 100 Not Yet 2 III Uttar Pradesh
05/024969 Grp A: Homoeopathic medicine Grp B: Placebo Yes Open COVID-19 Patients 100 Not Yet 3 III Uttar Pradesh
05/024986 Grp A:Homoeopathic medicine Arsenic album 30c Single arm NA COVID-19 Patients 10000 Not Yet 6 NA New Delhi
Interventional-Diagnostic
04/024776 Grp A: Chest X-Ray Artificial Intelligence Module, CT - Scan of THORAX Artificial Intelligence Module, Voice Sampling Artificial Intelligence Module Grp B: Normal subjects Chest X-Ray , CT-Scan Thorax and Voice sampling No NA COVID-19 Patients 1650 Open 3.5 NA Rajasthan
05/024983 Grp A: Topical Lignocaine Grp B: NA Single arm NA COVID-19 Patients 30 Not Yet 1 NA New Delhi
Interventional-Process of care change
05/024962 Grp A: Povidone Iodine Grp B: SALINE plus STANDARD of CARE as suggested by DCGI Yes NA COVID-19 Patients 96 Not Yet 3 NA Andhra Pradesh
05/025071 Grp A: Lowest driving pressure guided PEEPGrp B: Conventional lung protective ventilation strategy( ARDSnet protocol) Yes Single COVID-19 Patients 40 Not Yet 12 III New Delhi
Interventional- Nutraceuticals
04/024659 Grp A: SSV formulation Grp B: NA Single arm NA COVID-19 Patients 30 NA 6 III Maharashtra

Table 2

Observational studies

Observational Studies-Retrospective
Reg. ID CTRI/2020/…… Purpose Study Design Subject Sample Size Recrui-ment Status Estimate Duration (Months) State
04/024473 COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary) Retrospective data collection COVID-19 Patients 50000 Not Yet 256 M, 30 days New Delhi
04/024697 Formulation of a Clinical databank by consolidation of Indian data. Retrospective data collection COVID-19 Patients 100000 Not Yet 24 New Delhi
Observational Studies-Prospective
04/024442 Screening for symptoms of COVID-19 Follow up study COVID-19 Patients 5000 Not Yet 4 New Delhi
04/024413 Assessment of Knowledge, attitudes, and fear of COVID-19 Cross Sectional Study Healthy Human Volunteers 1000 NA* 14 days Dhaka Bangladesh
04/024482 evaluating the prophylactic efficacy of different regimens against SARS-CoV2 infection (COVID-2019) in asymptomatic health care workers Virtual Registry Study Healthy Human Volunteers 10000 Open 24 Tamil Nadu
04/024784 Assessment of Anxiety and depression during covid-19 Cross Sectional Study Healthy Human Volunteers 1000 Not Yet 12 New Delhi
04/024636 Objective clinical scoring system to rule out COVID-19 with high sensitivity Cohort Study COVID-19 Patients 1000 Not Yet 3 Rajasthan
04/024805 Impact of Covid-19 pandemic on practice pattern of Indian urologists Survey Healthy Human Volunteers 160 Not Yet 7 days Uttar Pradesh
04/024772 Comparison of suspected with confirmed cases of COVID-19 Cohort Study COVID-19 Patients 90 Not Yet 2 New Delhi
04/024859 Clinical characteristics and treatment Outcome of COVID-19 Patients Cross Sectional Study COVID-19 Patients 1000 Not Yet 12 New Delhi
05/025010 Hydroxychloroquine prophylaxis in Covid 19 infection Follow up Study Healthy Human Volunteers 2000 Not Yet 6 New Delhi
04/024914 Characteristics of seriously ill COVID-19 patients Cohort Study COVID-19 Patients 60 Not Yet 3 New Delhi
05/024982 Effects of using hydroxychloroquine and azithromycin in the treatment of confirmed COVID-19 positive patients Cross Sectional Study COVID-19 Patients 50 Not Yet 6 Chhattisgarh
05/025041 Radiographic findings and their temporal changes in COVID-19 positive patient Cohort Study COVID-19 Patients 200 Not Yet 12 New Delhi
05/025070 Issues and challenges in cancer patients on active treatment during the COVID-19 Cross Sectional Study COVID-19 Patients 150 Not Yet 12 New Delhi
05/025089 Effect of Hydroxychloroquine on QTc Interval Cohort Study Healthy Human Volunteers 50 Open 6 Uttar Pradesh
05/025091 Knowledge status of public about COVID 19 disease prevention and control Cross Sectional Study Healthy Human Volunteers 125 Not Yet 3 Tamil Nadu

[i] *A study from Bangladesh registered in CTRI but not recruiting the subjects from India

Discussion

The CTRI launched on 20th July 2007 is directed by the ICMR-National Institute of Medical Statistics, New Delhi, India. The CTRI is an online, free of cost and searchable platform for the registering all clinical studies prospective being conducted in India and was made mandatory by 1st April 2018.8 In the current pandemic situation of COVID-19, the discovery and development of a new drug is not an easy task. As the number of COVID-19 cases increasing progressively, the preventive medical option is in high demand. According to WHO, 2118 clinical trials have been registered on WHO international clinical trials registry during COVID-19 pandemic from all over the world and in this context China is on top.9 Despite, this much number of clinical trials registration all over the world, not a single drug (except Gilead-Remdesivir) is approved for the treatment of COVID-19.10

In India, 57 trials have been registered in CTRI for COVID-19 diagnosis, treatment, prevention and to assess treatment outcomes of existing therapies. Fourteen out of 40 interventional trials are in phase III and above of clinical trials and surprisingly, only two of these trials are open for recruitment. The average duration of completion of interventional trials is 6.3 months.

Treatment strategies

Anti-malarial

HCQ is an anti-malarial drug, which had been proved as having antiviral activity.11 In a study from China also stated that the HCQ may be a potential treatment option for COVID-19.12 In CTRI, seven drug trials investigating the effectiveness of Hydroxychloroquine (HCQ) for the treatment of COVID-19.

Antiprotozoal

In CTRI, Ivermectin and Niclosamide two antiprotozoal drugs have been registered to investigate treatment effectiveness for COVID-19. In the 1970s, Ivermectine was recognized as ‘Wonder Drug” because of its wide application in human and animal health. A study demonstrated the antiviral activity of ivermectin in it inhibit bovine herpesvirus 1 DNA polymerase nuclear import and interferes with viral replication.13 Niclosamide is an antiprotozoal drug having wide antiviral application; effectiveness as COVID-19 treatment could be expected.14

Antiviral

None of the antiviral drugs has been registered in CTRI for COVID-19 treatment. However, in the global clinical trials database, a large number of clinical trials have been registered to assess their effectiveness for the treatment of COVID-19. These trials include lopinavir/ritonavir, sofosbuvir/ledipasvir, favipiravir, umifenovir, triazavirin, baloxavir marboxil, azvudine, darunavir/cobicistat, sofosbuvir/ daclatasvir, and emtricitabine/tenofovir as investigational drug.9 Remdesivir is a broad-spectrum antiviral drug, had been used for the treatment of Marburg and Ebola viruses. A recent study has found Remdesivir having potential efficacy against COVID-19.15

Anticancer

Imatinib and Itolizumab two anticancer drugs have been registered in CTRI. The US National Library of Medicine clinical trial database (ClinicalTrials.gov) has registered a randomized, phase 2 clinical trial for investigating the effectiveness of imatinib mesylate as early treatment of COVID-19.16 Itolizumab is humanized IgG1 monoclonal antibody which selectively targets CD6. A phase 1 clinical trial to evaluate the safety, effectiveness and clinical activity of Itolizumab in subjects with moderate-to-severe uncontrolled asthma has been registered in ClinicalTrials.gov database.17

Biologics

A total of nine trials have been registered in CTRI including four Convalescent plasma, three BCG vaccine, one suspension of heat-killed (autoclaved) Mycobacterium w, and one of genetic mutation identification. Convalescent plasma (or immune plasma) is collected from COVID-19 infected and recovered individual (i.e., human antieSARS-CoV-2 plasma); transfused into infected patients as post-exposure prophylaxis.18 Several studies reported convalescent plasma as an effective preventive measure against COVID-19.19, 20 BCG vaccine has beneficial imprecise (off-target) effects on the immune system that defend against a wide range of other infections and are used routinely to treat bladder cancer. Several studies and trials are underway to generate evidence of use in COVID-19 prevention.21, 22

Ayurvedic

A total of seven studies have been registered for Ayurvedic drugs which include kashaya (Decoction) of Tinospora cordifolia, ZingiVir H, MyVir tablets, Dabur Chyawanprash, Shanshamani Vati or Sudarshana Ghanavati or Ashwagandha, Yashtimadhu tablet, Guduchi tablet. These Ayurvedic formulations are consisting of polyherbal drug which is used to strengthen the immune system and fight against infectious diseases. Enough clinical evidence is not available for the use of Ayurvedic drugs against COVID-19. However, Ministry of AYUSH published guidelines for safety precaution against COVID-19.23

Homeopathic

A total of four trials have been registered of homeopathic medicine Arsenicum album-30 is a common prescription medicine for respiratory infection, flu-like illness in daily practice which believed to be effective against COVID-19.24 One trial is of Cadamba, a medically potent plant having wide application in infectious as well as other disease and health condition.25 The use of Cadamba against COVID-19 is suspicious.

Diagnosis

The Real-Time Reverse Transcriptase (RT)-PCR Diagnostic tool detects the COVID-19 virus in upper and lower respiratory sampling.26 Now, CTRI registered a trial investigating the diagnostic tool such as a chest X-ray artificial intelligence module, CT-scan of thorax artificial intelligence module, in combination with voice sampling artificial intelligence module which may provide the better diagnosis. Another trial registered to asses decreases in the gag reflex while sampling for Covid-19 topical lignocaine.

Neutraceutical

A study has been registered in CTRI to investigate the immunity enhancing effect of SSV formulation (neutraceuticals) in COVID-19 patients.

Observational studies

A total of 17 observational (two retrospective and fifteen prospective) studies have been registered in CTRI. These COVID-19 studies have been designed for various objectives such as screening for symptoms, assessment of the knowledge, attitudes, and fear to evaluate the prophylactic efficacy of different regimens in asymptomatic health care workers, anxiety and depression during COVID-19, clinical characteristics and treatment outcome, hydroxychloroquine prophylaxis, radiographic findings and their temporal changes, knowledge status of the public.

The availability of new treatment modality against COVID-19 depends on the successful completion of the registered trial. Various factor affecting the completion of these trials such as COVID-19 itself a rapidly spreading infectious disease, large sample size, availability of research facilities/resources, and involvement of trained and skilled research staff, etc. may affect recruitment of subject and completion of trials resulting delay in trials result or outcomes.

However, the fast track approval of clinical trials, effective study design, making informed consent more “inform”, planning and scientific consideration over sample size, development of data safety monitoring board to supervise and ensure trial participants safety may enforce the successfulness of trials completion.27

After China, the world is suffering from the COVID-19 outbreak. Till the availability of an impactful medical weapon against COVID-19, standard care, supportive care, symptomatic treatment, personal hygiene, social distancing, etc. are the considerable tools helpful in combat against COVID-19. Now, India is almost completing three stages lockdown of almost 54 days (25th March to 17th May 2020) followed by an announcement of the 4th stage lockdown on 12th May 2020 to break the chain of COVID-19 infection. Even though, the cases of COVID-19 are increasing vigorously in Maharashtra (on top). This pandemic situation affected health, lifestyle, job, and economy to a great extent.

Conclusion

The world is combating against the COVID-19 outbreak. The availability of new health intervention against COVID-19 needs the more scientific, and collaborative center of attention towards drug development and clinical trials for COVID-19.

Source of Funding

None.

Conflict of Interest

None.

Acknowledgement

Nil.

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