scholarly journals Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry

Author(s):  
Angelika Batta ◽  
Raj Khirasaria ◽  
Vinod Kapoor ◽  
Deepansh Varshney

AbstractObjectivesWith the emergence of Novel corona virus, hunt for finding a preventive and therapeutic treatment options has already begun at a rapid pace with faster clinical development programs. The present study was carried out to give an insight of therapeutic interventional trials registered under clinical trial registry of India (CTRI) for COVID-19 pandemic.MethodsAll trials registered under CTRI were evaluated using keyword “COVID” from its inception till 9th June 2020. Out of which, therapeutic interventional studies were chosen for further analysis. Following information was collected for each trial: type of therapeutic intervention (preventive/therapeutic), treatment given, no. of centers (single center/multicentric), type of institution (government/private), study design (randomized/single-blinded/double-blinded) and sponsors (Government/private). Microsoft Office Excel 2007 was used for tabulation and analysis.ResultsThe search yielded total of 205 trials, out of which, 127 (62%) trials were interventional trials. Out of these, 71 (56%) were AYUSH interventions, 36 (28.3%) tested drugs, 9 (7%) tested a nondrug intervention, rest were nutraceuticals and vaccines. About 66 (56%) were therapeutic trials. Majority were single-centered trials, i.e. 87 (73.7%). Trials were government funded in 57 (48.3%) studies. Majority were randomized controlled trials, i.e. 67 (56.8%). AYUSH preparations included AYUSH-64, Arsenic Album, SamshamaniVati etc.ConclusionsThe number of therapeutic interventional clinical trials was fair in India. A clear-cut need exists for an increase in both quantity and quality of clinical trials for COVID-19. Drug repurposing approach in all systems of medicine can facilitate prompt clinical decisions at lower costs than de novo drug development.

2021 ◽  
Vol 14 (3) ◽  
pp. 280
Author(s):  
Rita Rebelo ◽  
Bárbara Polónia ◽  
Lúcio Lara Santos ◽  
M. Helena Vasconcelos ◽  
Cristina P. R. Xavier

Pancreatic ductal adenocarcinoma (PDAC) is considered one of the deadliest tumors worldwide. The diagnosis is often possible only in the latter stages of the disease, with patients already presenting an advanced or metastatic tumor. It is also one of the cancers with poorest prognosis, presenting a five-year survival rate of around 5%. Treatment of PDAC is still a major challenge, with cytotoxic chemotherapy remaining the basis of systemic therapy. However, no major advances have been made recently, and therapeutic options are limited and highly toxic. Thus, novel therapeutic options are urgently needed. Drug repurposing is a strategy for the development of novel treatments using approved or investigational drugs outside the scope of the original clinical indication. Since repurposed drugs have already completed several stages of the drug development process, a broad range of data is already available. Thus, when compared with de novo drug development, drug repurposing is time-efficient, inexpensive and has less risk of failure in future clinical trials. Several repurposing candidates have been investigated in the past years for the treatment of PDAC, as single agents or in combination with conventional chemotherapy. This review gives an overview of the main drugs that have been investigated as repurposing candidates, for the potential treatment of PDAC, in preclinical studies and clinical trials.


2020 ◽  
Vol 9 (1) ◽  
pp. 1695-1701 ◽  
Author(s):  
Peng Xu ◽  
Xiangyu Xing ◽  
Keying Yu ◽  
Zhiguo Lv ◽  
Huijing Cui ◽  
...  

2018 ◽  
Vol 48 (11) ◽  
pp. 995-1000 ◽  
Author(s):  
Nobuaki Ochi ◽  
Tatsuyuki Kawahara ◽  
Yasunari Nagasaki ◽  
Nozomu Nakagawa ◽  
Tomoko Yamagishi ◽  
...  

2019 ◽  
Vol 71 (2) ◽  
pp. 433-439
Author(s):  
Adam G Stewart ◽  
Patrick N A Harris ◽  
Mark Chatfield ◽  
Scott R Evans ◽  
David van Duin ◽  
...  

Abstract Treatment options for multidrug-resistant (MDR) gram-negative infection are growing. However, postregistration, pragmatic, and clinician-led clinical trials in this field are few, recruit small sample sizes, and experience deficiencies in design and operations. MDR gram-negative therapeutic trials are often inefficient, only evaluating a single antibiotic or strategy at a time. Novel clinical trial designs offer potential solutions by attempting to obtain clinically meaningful conclusions at the end or during a trial, for many treatment strategies, simultaneously. An integrated, consensus approach to MDR gram-negative infection trial design is crucial.


2017 ◽  
Vol 10 (2) ◽  
pp. 91-96 ◽  
Author(s):  
Mansoureh Feizabadi ◽  
Fatima Fahimnia ◽  
Alireza Mosavi Jarrahi ◽  
Nader Naghshineh ◽  
Shahram Tofighi

Author(s):  
Madhusmita Mohanty Mohapatra ◽  
Manju Rajaram ◽  
Dharm Prakash Dwivedi ◽  
Vishnukant Govindraj ◽  
Pratap Upadhya

Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2) which emerged in Wuhan initially as pneumonia of unknown origin in December 2019, later spread to whole world and became pandemic on 11th March, 2020. Many drugs have been proposed but are backed without clinical evidence. Scientific bodies are in the row to discover a reliable vaccine and effective drugs against the novel coronavirus. Many antiviral and anti-parasitic drugs which were thought to have some effect on Coronavirus disease 2019 (COVID-19) have been tried during the crisis but none have shown concrete evidence of action. Randomized clinical trials on the repurposed drugs are now registered under clinical trial registry to look at the safety profile and efficacy of the drugs to be used against SARS-CoV-2. Many meta-analyses are being conducted worldwide to frame evidence for the fight against this novel coronavirus. We are providing below a review of various drugs that have been tried for treatment of COVID-19 as well as different clinical trials which are underway.


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