I couldn't believe my eyes. So I asked my colleague to read to me the recent Covid19 guidelines by DGHS @MoHFW_INDIA. I couldn't believe my ears too.
The 9-page-PDF guides how to treat, investigate and monitor patients with Covid19 infection.
What is the first surprise? 1/N
Surprise 1.
Asymptomatic patients: "No investigation at this stage. And “No medications are required.”
No blood tests or fancy drugs for early Covid! 2/N
Surprise 2.
Mildly ill patients: May need investigations if symptoms persist or they deteriorate.
Paracetamol and cough syrup. Budesonide.
No other medicine required- So, no HCQ, Favipiravir, Ivermectin, Azithromycin, Doxycycline, Zinc and Vitamins. No plasma, either. 3/N
Surprise 3.
Moderately ill: Oxygen, control of co-morbidities, steroids, anticoagulants. Period. No coronil nor 2- DG.
4/N
Surprise 4.
Severely ill: oxygen, steroid, anticoagulants and clear indications for Tocilizumab. Clear criteria for prescribing.
Need for recruiting the hospital infection control committee. 5/N
Surprise 5.
Diagnostic tests specifically mentioned. No Ferritin and LDH after day 1.
Clear indications for a chest x-ray.
Irrational and rampant use of HRCT Chest heavily criticised.
7/N
“Exercise extreme caution when ordering an HRCT.”
Full page on HRCT. When HRCT is needed; 4 bullet points on why routine HRCT shouldn’t be done and 4 bullet points on when HRCT should not be ordered!
8/N
Surprise 6.
Full page on Remdesivir and Tocilizumab.
Advised to exercise extreme caution when ordering Remdesivir—“as this is only an experimental drug and has a potential to harm.”
Romance with remdesivir is over. This is unbelievable!
10/N
Surprise 7.
Full page on steroid and anti-coagulants.
Sensible, straightforward advice on steroid: Dexa— 6 mg a day, for 10- days, no taper, only in hypoxic patients.
Anticoagulants- prophylactic dose. Only in moderate or severely ill patients.
11/N
Surprise 8.
Full page on diagnosis, treatment and monitoring of Covid associated mucormycosis. The dose and duration of amphotericin B clearly spelt out. Clear guideline on when to switch to oral antifungal drugs.
12/N
Today David Sackett, the father of EBM, would have been so happy!
Very impressive and the authors deserve high praise for sticking to EBM in the national guideline- conscientious, explicit & judicious use of current best evidence in making decisions for treating Covid19.
13/13
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1/n The COLCORONA clinical trial (Lancet 27 May 2021) concludes that if we treat 70 Covid positive people with colchicine for a month, we prevent 1 hospital admission or death.
How did the researchers estimate the sample size of their study?
2/n Assumptions. They assumed that 7% of those on placebo shall either die or need hospital admission. Oral colchicine shall reduce this number to 5.25.
To detect a difference between the 2 arms of the study, they needed to enrol about 6000 people in the study. Which they did.
3/n The outcome in the colchicine trial was death or hospital admission. The secondary outcome was the need for mechanical ventilation.
Outcomes that are clinically meaningful. Outcomes that matter most to patients or their family.
I cringe when Times of India reports results from a COVID19 case-series from Maharashtra- drugs are doing great. Not a word on control arm or standard of care. They should ask—and tell us—who did they compare the drug with. These numbers are confusing and distort science. 1/4
First, #Favipiravir. Maharashtra reports that 5.5% (27/495) mildly sick COVID patients on Favipiravir died. Normally, about 98% of such patients recover. Are these results “encouraging”? Or should we be worried about the association of increased mortality with Favipiravir? 2/4
Second, #Remdesivir. The NEJM RCT showed that 7.1% on Remdesivir died compared to 11.9 % on placebo. The results lacked statistical significance. In Maharashtra, 29% (89/311) patients receiving Remdesivir died. Should we call these results promising? 3/4
My quick comments on the #Favipiravir study results released by #GLENMARK in a press release.
Did Favipiravir succeed in achieving faster viral clearance? No. The difference between the two arms of the study lacks statistical significance. The 95% CIs cross 1. N/1
What about secondary endpoints? Would you pay Rs 12500 for a drug that promises to make you fever-free a day earlier?
Look at the 95% CIs again- they barely float above 1! Not impressive! And were these patients hypoxic? The data does not tell us. 2/2
#Favipiravir group tended to require oxygen late compared to the usual care group.
OK. The trouble is, we do not know, eventually how many required oxygen in each group. 95% Cis touch 1- meaning no difference between the two groups. 3/4